Full-Time
Quality Engineer
Sustaining Engineer
PCI Pharma Services
1-10 employees
Pharmaceutical packaging and contract services
No salary listed
Philadelphia, PA, USA
In Person
First shift at the Philadelphia facility.
Bachelor's
 Manufacturing Quality & Test (1) |
|---|
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- A college or trade degree is required; an engineering degree or related scientific degree is preferred.
- At least three years of experience in an FDA-regulated industry is required, with strong preference for medical device or combination-product experience.
- Proficiency with personal computers, business software such as Microsoft Office, and technical software including enterprise resource planning and electronic quality management systems is required.
- Ability to create, use, and interpret scientific tables, charts, and graphs is required.
- Advanced computer skills and the ability to perform complex computer tasks and operate various computer programs are required.
- Full professional proficiency in speaking, reading, and writing is required for professional needs.
- Analytical ability to drive effective root cause analysis and critical thinking for complex problem solving is required.
- Support or drive all phases of the product quality lifecycle as products transfer from new product introduction into commercial operations.
- Directly support or drive technical and design transfer processes with appropriate risk management leadership.
- Ensure products are manufactured according to established control plans, design specifications, and product specifications.
- Drive continual improvement, standardization, simplification, and optimization of manufacturing, assembly, and final packaging processes.
- Assess, analyze, and trend incoming-material quality and lot-to-lot variation to reduce variation in the manufacturing process.
- Disposition non-conforming product and drive root cause investigations with corrective and preventive actions to prevent recurrence.
- Collaborate with internal teams, customers, suppliers, and contract service providers.
- Assist validation engineers with validation, qualification, and periodic change-assessment activities.
- Drive and support customer programs throughout the development lifecycle and support project milestones, scope changes, and business-development opportunities.
- Develop and implement product and process workflows and incorporate design for assembly and design for manufacturing into sustaining engineering and commercial operations.
- Perform test-method transfer and method-validation activities.
- Develop sampling plans for operational and performance qualification activities, including serialization and sterilization activities.
- Trend manufacturing data and contract service-provider results.
- Develop validation and requalification protocols.
- Develop master batch records, work instructions, and manufacturing and packaging documentation.
- Drive root-cause analysis of deviations and complaints.
- Support project teams in selecting design and manufacturing concepts and fundamental technology.
- Develop work standards and packages during project acquisition and delivery stages.
- Identify opportunities and develop recommendations to improve product and process design.
- Interpret product requirements and design and develop concepts, components, assemblies, and products in compliance with quality-system procedures and applicable industry and business standards.
- Generate documentation including measurement system analyses, control plans, process flow maps, inspection plans and techniques, gauge repeatability and reproducibility analyses, and test requirements.
- Maintain quality-engineering process discipline across manufacturing strategy, capability analysis, failure mode and effects analysis, tooling selection, risk management, cost modeling, design for manufacturing, and process validation and qualification.
- Use data-driven tools and methodologies to implement structured and timely problem solving.
- Develop and review technical specifications.
- Participate in external audits of suppliers and contract service providers.
- Manage internal and external suppliers supporting product-design tasks.
- Track and trend raw materials and key components to measure variation and part quality over time and drive improvement with suppliers.
- Collaborate with engineering, commercial operations, procurement, and ancillary groups on high-priority product-program initiatives.
- Present quality standards, process flows, inspection plans, and issues to internal stakeholders and external clients.
- Support recruitment, coaching, and development of quality engineers as programs scale.
- Perform other duties assigned by the manager or supervisor and assist new product introduction activities as needed.
- Lean Six Sigma certification, ASQ Certified Quality Engineer certification, or similar certification is highly desirable.
- Strong organizational, time-management, and multitasking skills are preferred.
- Prior experience in technical writing and use of root-cause analysis tools is preferred.
- Critical-thinking skills and a collaborative approach are preferred.
- Technical knowledge and experience with test-method validation, medical devices, and sterilization processes are preferred.
PCI Pharma Services offers end-to-end pharmaceutical packaging and related services, including Folding Cartons, Labels, Contract Packaging, Clinical Services, and Brand Protection. It serves as a one-stop source for healthcare product developers and manufacturers, handling carton and label production, packaging operations, clinical services, and brand protection under one roof. The company stands out with eight decades of experience, strict cGMP and ISO compliance, lean manufacturing, ongoing R&D, and comprehensive employee training, security, hygiene, and inspection practices. Its goal is to be a trusted, end-to-end packaging partner that delivers reliable, compliant, and scalable packaging solutions, so clients can focus on their core business.
Company Size
1-10
Company Stage
Debt Financing
Total Funding
$4B
Headquarters
Burlington, Canada
Founded
1971
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Simplify's Take
What believers are saying
- April 2026 investment exceeds $1 billion, adding capacity through 2028.
- Bedford line began full-scale production in April 2026, reaching 33 million vials annually.
- Bain Capital, Kohlberg, and Mubadala reinvested in July 2025, backing expansion.
What critics are saying
- NLRB case filed February 11, 2026 alleges bad-faith bargaining with United Steelworkers Local 286.
- Illinois civil-rights suit against PCI remained active in July 2026, adding reputational drag.
- San Diego’s 2028 line delays revenue; execution misses would undercut the $1 billion thesis.
What makes PCI Pharma Services unique
- PCI spans sterile fill-finish, device assembly, packaging, and development across 38 GMP facilities.
- January 2026 acquisition of Ajinomoto Althea created San Diego prefilled-syringe scale.
- Bedford and Rockford buildouts support autoinjectors, cartridges, and high-potent biologics.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Paid Vacation
401(k) Retirement Plan
Health Savings Account/Flexible Spending Account
Company News
Atsushi Watanabe to become president of PCI Holdings May 20, 2026 17:59 Atsushi Watanabe: Graduated from Shinshu University's Faculty of Economics in 1986 (Showa 61). Joined Kyodo VAN (now SCSK). Became president of SCSK Serviceware in 2022 and director of Lester in April 2026. Born in Hyogo Prefecture. Aged 64. (Will become president on June 23. Current president Kensaku Morishita will become senior managing director) All articles freely readable Paid members get first month free AI trained on Nikkei online edition articles
PCI Pharma Services makes $1B investment to scale injectable manufacturing, device assembly. By Pharma Manufacturing - Facilities - April 29, 2026 - 5 min Philadelphia-based PCI Pharma Services, a global contract development and manufacturing organization (CDMO), has announced a series of infrastructure investments aimed at expanding its sterile fill-finish and advanced drug delivery capabilities, as demand for injectable therapies and supply chain resilience continues to reshape the pharmaceutical industry. The investments are part of a broader commitment exceeding $1 billion across PCI's U.S. and European operations, meant to reinforce the CDMO's ability to support drug product development and manufacturing, clinical trial supply, and drug-device combination assembly from clinical stages through commercial launch. Central to the announcement is a $100 million investment at PCI's San Diego campus, where the company will install a high-speed isolator filling line for ready-to-use (RTU) prefilled syringes and cartridges. The new line, expected to be operational in the first half of 2028, will more than double the site's existing syringe and cartridge capacity, which already supports more than 45 FDA-approved products. The San Diego campus also hosts large-scale aseptic filling for prefilled syringes and cartridges, alongside specialized capabilities in oligonucleotides, peptides, complex formulations, and lyophilization for injectables such as nanoparticles, mRNA, monoclonal antibodies, proteins, and highly potent products. Chief Commercial Officer Tim Roberts told Pharma Manufacturing these investments reflect a broader shift toward injectable drug formats, driven in part by the rapid rise of GLP-1 therapies and other biologics that are increasingly administered outside traditional healthcare settings. This trend is also extending into more complex therapeutic areas, including oncology and central nervous system (CNS) disorders, making drug-device combinations more central to how therapies are developed and delivered, according to Roberts. "Now those next-generation medicines for oncology, CNS, and rare diseases no longer need to be delivered strictly by healthcare professionals," says Roberts. "That accepted technology of pens, autoinjectors, and on-body devices is now being recognized by pharma companies and payers as the forward modality of how these lifesaving medicines can be delivered in a much more patient-centric way." In parallel, PCI's Bedford, New Hampshire site is commissioning a GMP-ready isolator vial and lyophilization line capable of producing batches of up to 300,000 vials at 400 units per minute - equating to approximately 33 million units annually - following the start of full-scale production in April. The campus will also bring online a customer-dedicated high-potent sterile fill-finish line, according to the company. Both sites are also being outfitted with advanced automated visual inspection (AVI) systems for sterile fill-finish applications. According to Roberts, these systems enhance defect detection - including particulates and cosmetic issues - while enabling rapid, highly accurate inspection of both containers and drug products, helping expand capacity without compromising quality. PCI's U.S.-based AVI infrastructure includes annual accommodation for 40 million blister units, 70 million bottles, and 75 million vials. "It can do these things very quickly and very accurately," Roberts said of the AVI systems. "In investing in AVI systems to this degree, PCI is furthering its ability to have ample room without sacrificing mission-critical quality control." The company has also committed to multiple buildouts of autoinjector and drug-device combination assembly infrastructure, in partnership with leading device manufacturers, at its campuses in Philadelphia and Rockford, Illinois. These upgrades are being introduced in phases over the next six months and are designed to expand both capacity and operational scale of its clinical-through-commercial capabilities. PCI plans to add a third autoinjector assembly line in 2027, which will bring its total U.S. capacity for autoinjector and device assembly to more than 250 million units annually. The lines are designed for high-speed, flexible manufacturing, with the ability to support multiple device formats, while dedicated prefilled syringe safety device capabilities add labeling and secondary packaging options. That growth aligns with what Roberts describes as a clear shift across the development pipeline, with more clinical programs - and ultimately commercial products - moving toward delivery formats such as prefilled syringes, pens, and autoinjectors. These systems support self-administration and are also enabling more decentralized clinical trial models, reducing the need for frequent site visits and potentially improving patient participation and retention. PCI's integrated model, spanning prefilled syringe manufacturing through final device assembly and packaging, is designed to support that continuity. The company's Packaging Centers of Excellence in Philadelphia and Rockford provide capacity for both oral solid dose and injectable products, along with cold chain storage and the ability to rapidly support programs at clinical or commercial scale. Across the two sites, available capacity includes approximately 40 million blister units, 70 million bottles, and 75 million vials annually. In conjunction with expanding its manufacturing platform, PCI is also investing in dedicated Development Centers of Excellence (CoE) in Bedford, New Hampshire, and León, Spain. These centers will support a range of development activities, including lyophilization, formulation, analytical services, drug-device combination development, long-acting injectables, and ophthalmic products, according to the company. The CoEs are designed to handle both highly potent and non-potent, small-molecule and biologic modalities across vials, prefilled syringes, and cartridges. The Bedford Development CoE is expected to be operational this May, with the León site slated for June. Andy Lundin has more than 10 years of experience in business-to-business publishing producing digital content for audiences in the medical and automotive industries, among others. He currently works as Senior Editor for Pharma Manufacturing and is responsible for feature writing and production of the podcast. His prior publications include MEDQOR, a real-time healthcare business intelligence platform, and Bobit Business Media. Andy graduated from California State University-Fullerton in 2014 with a B.A. in journalism. He lives in Long Beach, California. Recent Comments
On the last day of June 2025's BIO conference in Boston, Massachusetts, contract development and manufacturing organization (CDMO) PCI Pharma Services bused a crowd of delegates to its manufacturing site in Bedford, New Hampshire where it hosted a tour of its 50,000 square-foot expansion.
PCI Pharma Services in Northeast Philadelphia has received a multibillion-dollar investment from Bain Capital and Kohlberg, valuing the company at $10 billion. Kohlberg had previously invested in PCI, while Bain is a new investor. The investment will help PCI expand its services and geographic reach. The company currently operates 38 sites across seven countries and employs over 7,500 people.
Healthcare & life sciences Private Equity deal tracker: Bain Capital and Kohlberg invest in PCI Pharma.