SUMMARY

Responsibilities include review of line documentation related to contract packaging. Will follow up on customer inquiries as they relate to same documentation and compliance issue. Complete final review and release for product distribution. The impact of review process directly impacts company compliance to regulatory requirements and customer satisfaction.

ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of responsibilities related to record review. Other duties may also be assigned.

Responsible for review of documentation related to primary, secondary, and clinical packaging after completion of reconciliation.

Responsible for critical review and logging of all above documentation for errors, omissions, over-writes and compliance to cGMPs, customer specifications, and internal SOP’s.

Responsible for follow-up on all customer inquiries specific to documentation related to the packaging, testing and release of the work in-process or finished product.

Responsible for final release of work in-process or finished product.

Responsible for reviewing and maintaining the QAD Item Master Maintenance and Router Maintenance.
Responsible for logging and maintaining packaging process samples as well as coordinating shipment of samples to customers.

Responsible for maintaining and filing of documentation related to packaging in current appropriate status locations.

Responsible for entering lot specific information into the Quality Dashboard (Access Database).

Responsible for participating in internal, customer, and regulatory audits at the discretion of senior management.

Other responsibilities as required.

SUPERVISORY RESPONSIBILITIES: None

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duties and responsibilities satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

High School Degree is required. One to two years related pharmaceutical experience and/or training; or equivalent combination of education and experience is preferred. Experience in pharmaceutical or related industry is desired.

- General knowledge of FDA regulations related to cGMPs required.

- General knowledge of cGDPs required.

- General knowledge of quality control/assurance required.

- General knowledge of DEA regulations preferred.

- Excellent detail skills as they apply to documentation review and compliance required.

- Good written and oral communication skills required.

- Good organizational and planning skills required.

- Excellent interpersonal skills required.

REQUIREMENTS:

Due to the nature of our work, all employees must be over the age of 18 and will be required to undergo a pre-employment drug test and background check.

MATHEMATICAL SKILLS:

Ability to apply moderately complex mathematical operations including an understanding of statistical sampling plans and the ability to calculate time, percentages, and decimals. Basic math skills (addition, subtraction, multiplication and division) are required.

LANGUAGE SKILLS:

Ability to respond to common inquiries or complaints from customers. Ability to respond to inquiries from peers and superiors. Ability to effectively present information to the following groups:

- Internal: Frequent contact with Quality Department, Project Managers, New Business Development, Material Management and Operations Department employees for information on quality documentation issues and cGMP issues.

- External: Occasional contact with customer representatives related to documentation.

REASONING ABILITY:

Ongoing contact with internal Sharp Operations, Project Managers, New Business Development, Material Management and Quality Department employees. Frequent contact with customer representatives concerning documentation issues, as well as cGMP’s. A thorough understanding or each aspect of the job is required. Good organizational skills are necessary. Good reasoning skills for analysis and problem solving are needed.

COMPUTER SKILLS:

Must be proficient in Microsoft Office Suite, Adobe Acrobat, and QAD. Experience with Pilgrim SmartSolve system desired.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands, speak and listen. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

About the company

Sharp Packaging Services provides integrated pharmaceutical services globally, including clinical supply chain, contract manufacturing, packaging, and distribution for pharmaceutical and biotech clients. Its work spans sterile fill-finish to gene therapy packaging, offering end-to-end solutions from development to market. It differentiates itself with global reach, end-to-end capabilities across clinical and commercial production, niche capabilities like gene therapy packaging and serialization, and ongoing investments in technology and facilities. Its goal is to help clients bring new drugs to market faster and more cost-effectively through specialized packaging, manufacturing, and distribution.

Company Size

1,001-5,000

Company Stage

Debt Financing

Total Funding

$712.5M

Headquarters

Allentown, Pennsylvania

Founded

1993

Get referred to Sharp Packaging Services

See people who can refer or advise you

Simplify's Take

What believers are saying

September 2026 adds 4,400 pallet locations and new 2-8°C storage for biologics.
January 2026 and October 2025 expansions add sterile fill-finish, OSD, and European packaging capacity.
October 2025 $100 million program and Lee, Massachusetts isolator line deepen commercial manufacturing scale.

What critics are saying

Q1 2027 and Q1 2028 line ramps risk delays from validation failures and equipment integration.
Sharp’s injectable bet concentrates capital in autoinjectors, pens, and cold-chain demand shifts.
West, Catalent, and PCI Global squeeze pricing, forcing Sharp to defend margins aggressively.

What makes Sharp Packaging Services unique

Sharp’s 30+ clinical depots and four-country GMP network support global launches.
September 2026 autoinjector expansion spans Macungie, Bethlehem, and Belgium across clinical-to-commercial scales.
July 2026 CTO hire from West Pharmaceutical Services strengthens digital manufacturing and enterprise systems.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Hybrid Work Options
Remote Work Options

Growth & Insights and Company News

Headcount

6 month growth

13%

1 year growth

13%

2 year growth

13%

Sharp

Sep 22nd, 2026

Sharp expands autoinjector and pen assembly capacity in US and EU to support growing injectable demand.

Sharp expands autoinjector and pen assembly capacity in US and EU to support growing injectable demand. * 22 Sep 2026 Additional device assembly and cold storage capabilities strengthen Sharp's global clinical-to-commercial support for injectable programs [Allentown, PA, 22 September 2026] - Sharp Services, a leader in pharmaceutical packaging, clinical trial services and sterile manufacturing, today announced progress on the expansion of its autoinjector and pen assembly network. Building on its previously announced $20 million investment, Sharp is adding assembly capacity to support injectable programs as well as additional 2-8°C temperature-controlled storage designed to support clients as they progress from development through commercialization. "Injectable assembly and packaging programs have different requirements as they move from the clinic to commercialization, and our clients need a partner that can support that progression," said Jeff Benedict, Chief Commercial Officer of Sharp. "By investing in assembly and packaging capacity across the product lifecycle, along with additional 2-8°C cold storage required for sensitive biotech drug products, we are positioned to offer clients greater flexibility to advance and scale their programs with Sharp." At Sharp's Macungie, Pennsylvania facility, a low-speed assembly line capable of two autoinjectors or pen devices per minute is expected to be operational by first quarter of 2027, followed by a 50 autoinjectors per minute mid-speed line by the first quarter of 2028 as commercial programs scale. The site has also added two temperature-controlled storage units providing more than 4,400 additional pallet locations for sensitive biotech drug products, with occupancy anticipated in the fourth quarter of 2026. Combined with available space for future expansion, the facility offers the flexibility to support programs through either Sharp-invested production lines or the integration of client-owned equipment, helping clients scale with confidence. To support autoinjector and pen programs across all stages of clinical development through low-volume commercial supply, particularly for rare disease and orphan drugs, Sharp is adding a low-speed assembly line dedicated to these projects at its Bethlehem, Pennsylvania facility. This line will assemble up to two autoinjector or pen devices per minute and is expected online in the first quarter of 2027. Bethlehem has also recently completed their 2-8°C and -20°C cold room expansion which has doubled storage capacity and added an additional 2-8°C packaging suite to meet growing demand. To provide greater capacity for autoinjector and pen solutions in Europe, Sharp is expanding its capabilities in Belgium with new assembly equipment ranging from two devices per minute up to 100 devices per minute, along with functional testing, and a new fully automatic 2-8°C warehouse. The investment further strengthens Sharp's global network, providing scalable support for drug delivery device programs at every stage of development and commercial supply. About Sharp Sharp helps pharmaceutical and biotech companies bring therapies to patients worldwide. As a specialist CDMO, Sharp Services, LLC provide commercial packaging, clinical trial, and sterile manufacturing services. For more than 70 years, Sharp Services, LLC has helped clients navigate complexity across the product lifecycle - from pre-clinical development through commercial launch and beyond. With facilities in the United States, United Kingdom, Belgium, and the Netherlands, and a global network of more than 30 clinical depots, Sharp Services, LLC support its clients with the precision, quality and reliability they can lean on. Sharp Services, LLC is a team of 2,500+ united by its common purpose which is to help make lives better. Sharp consistently invests in the global capacity its clients need to innovate, evolve, and deliver. So, their therapies reach the patients who need them.

Sharp

Jul 9th, 2026

Sharp appoints Nakul Subramaniyan as Chief Technology Officer to lead global digital and technology strategy.

Sharp appoints Nakul Subramaniyan as Chief Technology Officer to lead global digital and technology strategy. * 9 Jul 2026 June 2026: Sharp Services, a leader in pharmaceutical packaging, clinical trial services and sterile manufacturing, has appointed Nakul Subramaniyan as Chief Technology Officer of Sharp. In his role as CTO, Nakul will lead Sharp's global technology strategy, enterprise systems, IT infrastructure, and digital transformation initiatives. He joins Sharp's Senior Leadership Team and reports directly to Kevin Orfan, President and CEO of Sharp. "I am delighted to welcome Nakul to Sharp as we continue to strengthen our global technology capabilities," said Kevin Orfan. "Nakul has the technical vision, industry expertise and transformation experience needed to advance our digital strategy and strengthen service delivery across our packaging, clinical and sterile businesses." Nakul brings extensive experience to Sharp in pharmaceutical manufacturing, digital transformation and enterprise technology. He will focus on driving innovation, scalability, and operational excellence across Sharp's global operations, building on the technology foundation that supports clients from early development through commercial launch. Before joining Sharp, Nakul served as Vice President, Digital & Transformation at West Pharmaceutical Services where he led global digital manufacturing, enterprise platforms, and the technology transformation agenda. "I am excited to join Sharp at this important stage in its growth," said Nakul Subramaniyan. "Technology has a critical role to play in enabling scalable, connected, and reliable services for pharma and biotech clients. In regulated life sciences, digital capability has to be practical, secure, and trusted, and I look forward to helping build capabilities that support Sharp's clients throughout their drug development lifecycle and, ultimately, the patients our industry serves." Nakul, who will be based at Sharp's headquarters in Allentown, PA, holds a Bachelor of Technology degree from Jawaharlal Nehru Technological University and a Master of Information Science and Technology from Missouri University of Science and Technology. About Sharp. Sharp is a leader in commercial packaging, clinical services & sterile manufacturing. For 70+ years, Sharp Services, LLC has provided solutions to pharma and biotech clients from phase I trials through to commercial launch and supply, and lifecycle management. With facilities in the United States, United Kingdom, Belgium & the Netherlands and 30+ clinical depots globally, covering every region of the world, its experience is your strength. Its full complement of integrated services includes research and development, clinical manufacturing, sterile development and fill/finish services, primary and secondary packaging of both investigational and commercial product, package design, serialization and aggregation, storage, distribution and clinical IRT. Sharp also offers Qualified Person (QP) services to meet the complex regulatory demands of drug product release in the EU and UK.

Packaging Insights

Jun 19th, 2026

Eisai invests £48M in UK cold-chain pharma packaging hub.

Eisai invests £48M in UK cold-chain pharma packaging hub. 19 Jun 2026 Key takeaways. * Eisai is investing approximately £48 million (US$63.5 million) at its Hatfield, UK, site to build cold-chain packaging and supply capabilities. * The project, supported by the UK Government's LSIMF, aims to strengthen domestic pharma manufacturing and improve supply resilience. * The investment will allow Eisai to bring more packaging operations in-house. Eisai, a Japanese pharmaceutical company, has announced an investment, supported by the UK government under the Life Sciences Innovative Manufacturing Fund (LSIMF), at its manufacturing site in Hatfield, UK, to establish supply chain and packaging capabilities for medicines that require cold-chain management. LSIMF is a capital grants scheme aiming to enhance life sciences manufacturing capabilities in the UK and improve supply resilience. The project is being implemented in multiple phases, with a total investment from Eisai of approximately £48 million (US$63.5 million). Haruo Naito, CEO at Eisai, says: "This strategic investment reflects our long-term commitment to strengthening resilient supply capabilities for our innovative medicines and pipeline products, while further deepening our long-standing relationship with the UK. We value the opportunity to work with the UK government in strengthening life sciences manufacturing and healthcare resilience for the future." Strengthen pharmaceutical manufacturing resilience. The investment is said to align with the UK government's policy to strengthen domestic pharmaceutical manufacturing. The Hatfield site aims to serve as a manufacturing hub serving multiple regions, including Europe, the Middle East, and Africa. Lord Vallance, Minister of State for Science, says: "Building world-class manufacturing capabilities here in the UK will secure the supply of vital medicines, including treatments for Alzheimer's disease, that can transform lives. Eisai's government-backed investment will also support the creation of new skilled jobs in Hatfield and is another example of the benefits of international companies investing in the UK - bolstering our reputation as a life sciences hub while growing our economy." According to Eisai, the investment will help expand the company's manufacturing capabilities, "broadening its role beyond traditional oral solid dose operations to support the packaging and supply of temperature-controlled medicines for injection and infusion." Moreover, the company is set to enhance supply stability and flexibility by transitioning from reliance on external contract manufacturers to an in-house packaging model. The investment covers facilities capable of handling temperature-controlled products, including the expansion of goods receipt and dispatch functions, construction of ambient and cold-chain warehouses, along with installation of packaging buildings and packaging lines. In addition, the site's advanced production flexibility, capacity for multilingual and small-batch packaging, and robust quality management systems will support Eisai's global supply network. In related pharmaceutical packaging manufacturing news, this month, Amcor boosted its healthcare packaging production capacity with a multi-million-dollar investment in its facility in Sira, Karnataka, India, and with a US$35 million investment to open a healthcare packaging coating facility in Subang Jaya, Selangor, Malaysia. Earlier this year, Sharp, a pharmaceutical packaging company, invested over €20 million (US$21.6 million) in its European packaging facilities in response to "strong market demand" for injectables.

PharmTech

Jan 21st, 2026

Sharp Expands European Injectable Packaging Capacity With €20 million Investment

Sharp expands European injectable packaging capacity with €20 million investment. Sharp increases European injectable assembly and secondary packaging capacity to support the rising demand for pre-filled syringes and autoinjectors. As the pharmaceutical landscape continues to shift toward biologic drug delivery, the technical requirements for secondary packaging and cold chain logistics have become increasingly complex. To address these demands, Sharp is expanding its infrastructure in Hamont-Achel, Belgium, and Heerenveen, The Netherlands, focusing on the assembly and such as autoinjectors, pen devices, pre-filled syringes, and vials, according to a press release from the company (1). These expansions represent a significant shift in available regional capacity for the European market. How is technical capacity evolving to meet injectable drug delivery requirements? The modernization of these facilities reflects the growing need for specialized environments to handle sensitive injectable products (1). In the Netherlands, the expansion involves increasing (GMP) production capacity, which includes the installation of two Grade D packaging suites scheduled to be operational in 2026. These suites are designed to accommodate new vial packaging and syringe assembly programs, providing the necessary controlled environments for high-value biologics. Simultaneously, the Belgian facility is undergoing a major transformation to resolve potential bottlenecks in storage and assembly (1). The project will quadruple existing cold-chain warehouse capacity and double the available ambient storage space. To further streamline the transition from development to market-scale production, a new syringe assembly and blister packaging suite is being added, with plans for further device assembly and packaging lines. For manufacturing leads, the integration of collaborative robot technology onto pre-filled syringe and autoinjector packaging lines is a notable development aimed at enhancing production efficiency and consistency. Why do these infrastructure updates matter for long-term supply chain resilience? Beyond immediate throughput, the expansion aligns with the industry's focus on sustainable manufacturing and reliable market entry within the European Union (1). The Belgian site has been upgraded with a carport solar system designed to supply 50% of the facility's electricity once it is fully commissioned in mid-2026. This focus on renewable energy allows pharmaceutical partners to meet internal sustainability targets while maintaining a robust supply chain. Robert O'Beirn, managing director, Sharp Clinical & Sharp Europe, commented in a Sharp press release: "Our European facilities have a long-established reputation for successfully delivering the complex packaging services required for injectable drug formats. This investment represents a significant increase in our capacity to support our pharma clients, as sustainably as possible, with their injectable drug launches in the EU market" (1). By increasing the scale of available GMP space and incorporating advanced automation, these upgrades provide a pathway for pharmaceutical developers to navigate the regulatory and logistical hurdles of launching injectable therapies. The combination of expanded cold storage and specialized assembly capacity ensures that the infrastructure can support the full lifecycle of complex drug delivery devices. How is the investment part of Sharp's larger plans? In October 2025, Sharp announced plans to invest $100 million across its United States and European facilities to expand capacity for injectable and oral solid dose medications (2). This initiative addresses rising market demand for autoinjectors and pre-filled syringes through modernized assembly lines and sterile filling. Technical infrastructure upgrades announced by Sharp at the time (2): - Injectable Assembly: New packaging suites and automated lines are being established in Pennsylvania, Belgium, and the Netherlands to support complex delivery formats. This expansion provides pharmaceutical developers with increased regional manufacturing capacity and sustainable production options for global commercial launches. Get the essential updates shaping the future of pharma manufacturing and compliance - subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Packaging Gateway

Jan 20th, 2026

Sharp to invest in European injectable packaging expansion

Sharp to invest in European injectable packaging expansion. The funds will be used to upgrade sites in Hamont-Achel, Belgium, and Heerenveen, the Netherlands. Pharmaceutical packaging company Sharp has committed more than €20m ($23.4m) to expand its European facilities amid demand for injectable products. The funds will be used to upgrade sites in Hamont-Achel, Belgium, and Heerenveen, the Netherlands. The focus will be on enhancing capabilities for assembling, labelling, packaging, and cold storage of various injectable types such as autoinjectors, pre-filled syringes, pen devices, and vials. At its Belgian facility, Sharp will increase cold-chain warehouse space fourfold and double ambient storage capacity. The site is also set to receive a new suite for syringe assembly and blister packaging. Plans are in place to further boost device assembly and packaging operations. US tariffs are shifting - will you react or anticipate? Don't let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. To support efficiency on adjacent packaging lines for pre-filled syringes and autoinjectors, the company has introduced collaborative robot technology. A new solar-powered carport has also been installed at the Hamont-Achel site to provide renewable energy. Once fully commissioned by mid-2026, this system is expected to supply 50% of the facility's electricity needs from renewable sources. The Heerenveen site in the Netherlands will see an expansion of GMP production capabilities through the addition of two Grade D packaging suites. These improvements aim to support upcoming syringe assembly and packaging projects, as well as increased vial packaging capacity planned for 2026. Sharp Clinical & Sharp Europe managing director Robert O'Beirn said: "Our European facilities have a long-established reputation for successfully delivering the complex packaging services required for injectable drug formats. "This investment represents a significant increase in our capacity to support our pharma clients, as sustainably as possible, with their injectable drug launches in the EU market." This European expansion forms part of a broader $100m investment programme announced by Sharp in November 2025. In May 2024, the company expanded its Macungie facility in Pennsylvania, US, to address greater demand for secondary packaging of sterile injectables.

Sharp Packaging Services

Batch Record Reviewer

About the job