Piramal Pharma

CDMO and hospital generics, consumer health

Manager Packaging Technology

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours

Full-timeHyderabad, Telangana, IndiaNo salary listedIn-person

About the Job

Requirements

A bachelor's degree in Mechanical Engineering or a graduate qualification in Packaging Technology, with experience in sterile packaging development and exposure to medical device development.
Eight to fourteen years of professional experience in the pharmaceutical industry, preferably with sterile products, or in the medical device industry.
Experience developing primary container designs and specifications and supporting primary packaging-related regulatory filings.
Project management skills and a proven track record within packaging and/or engineering.
Experience writing technical documentation for regulatory files, including FDA 510(k) and CE Mark technical files.
Strong understanding of global regulations regarding packaging and medical devices.

Responsibilities

Develop, test, validate, and commercialize packaging solutions and medical devices for new and existing products with cross-functional teams.
Support continuous improvements, problem resolution, and redesign for marketed products.
Work on new product development, prepare technical documentation for regulatory files, conduct performance analysis and risk management, and transfer designs to manufacturing.
Design packaging systems for anesthetic and sterile drug products, including ampoules, vials, and prefilled syringes, covering primary, secondary, and tertiary components and packaging-process automation equipment.
Handle contract manufacturing organization sites for the injectable vertical and provide complete documentation support, including eMPD and eSPEC.
Develop 3D computer-aided design and SolidWorks models of parts and assemblies, and create engineering drawings for products, components, and tooling.
Coordinate with manufacturing, supply chain management, and logistics teams to understand challenges and improvement opportunities.
Use 3D printing and additive manufacturing for prototyping and low-volume production.
Develop components and support stability studies, machine feasibility studies, packaging trials, regulatory filings, shipping studies, and validation.
Select components and materials for product designs and development.
Prepare protocols and testing procedures in accordance with ASTM and ISO standards, and analyze and interpret test data.
Prepare technical documentation for regulatory files, including FDA 510(k) and CE Mark technical files.
Create, improve, and maintain Design Control and Quality Management System procedures with Quality and Regulatory teams.
Perform root-cause analysis; recommend, write, and implement corrective and preventive actions; verify their effectiveness; and provide training as required.
Create product-priority timelines and coordinate with team members.
Develop, review, and approve packaging component specifications and drawings, design history files for combination products, project value-stream mapping, and bulk and finished drug-product procedures.
Support primary packaging-related regulatory filings.
Support distribution testing, shipping studies, line trials, packaging-material qualifications, child-resistant requirements, human-factor studies, and patient-centric designs.
Identify and validate secondary and tertiary packaging materials and suppliers.
Execute harmonization and standardization, quality-risk remediation and reduction, and continuous-improvement projects.
Develop, track, and maintain project plans and budgets for packaging-related projects.
Originate and develop packaging projects and initiatives that improve processes and create significant business impact.
Support sustainability and green-packaging initiatives as required by the organization.

Desired Qualifications

Sterile product experience is preferred.

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Job Description

Manager - Packaging TechnologyBusiness: Piramal Critical Care Department: Packaging Technology Location: Hyderabad Travel: MediumJob Description Business: Piramal Critical Care Department: Packaging Technology Location: Hyderabad Travel: Medium Job Overview: The Packaging development engineer will be responsible to work for various packaging projects. He/ She will work with cross functional teams to develop, test, validate, and commercialize package solutions / Medical devices for both new and existing products. He/she will support continuous improvements as well as problem resolution and redesign when required for marketed products. The candidate will work on new product development, preparation of technical documentation for regulatory files (i.e., FDA 510k and CE mark technical files), performance analysis, risk management, and design transfer to manufacturing. Key Stakeholders: Internal: Supply Chain, CMO sites, QA, RA and Manufacturing site colleagues Key Stakeholders: External: Pkg Material suppliers Reporting Structure: Role reports to: Chief Manager Packaging Technology Qualification: BS, Mechanical Engineer / Graduate in Packaging Technology with experience in sterile packaging development along with exposure in Medical device development function. Experience: - Bachelor’s degree with 8-14 years of professional experience in pharmaceutical (sterile product experience is preferred) or medical device industries - Experience in developing primary container designs and specifications and supporting primary packaging related regulatory filings - Project management skills with proven track record within Packaging and/or Engineering - Experience in writing technical documentation for regulatory files (i.e., FDA 510k and CE mark technical files) - Strong understanding of global regulations regarding packaging & medical device regulations. Key Roles/Responsibilities: - Designing packaging systems for the anesthetic and sterile drug products (ampoule, vial and PFS) including primary, secondary, and tertiary packaging components as well as equipment automation for the packaging process. - Handling of CMO sites for the Injectable vertical along with complete documentation support (eMPD , eSPEC). - Development 3D CAD & SolidWorks models of parts and assemblies along with creation of engineering drawings for product, components, tooling, etc. - Coordinate with manufacturing / SCM / Logistic team to understand the challenges/improvement scope. - Leverage 3D printing & additive manufacturing processes for prototyping and low-volume production - Strong experience in component development including and not limited to knowledge of stability studies/machine feasibility study/packaging trials, Regulatory filing, shipping studies and validation. - Selection of components and materials for use in product designs and development. - Preparation of the protocols, testing procedures as per ASTM & ISO standards, analysis, and interpretation of test data. - Preparation of technical documentation for regulatory files (i.e., FDA 510k and CE mark technical files) - Create, improve, and maintain Design Control and Quality Management System procedures in collaboration with Quality and Regulatory. - Perform root cause analysis, provide recommendations, write, implement corrective/preventive actions, verify effectiveness and train per requirement. - Create product priority timeline and coordination with team members - Developing, reviewing, and approving the following packaging documents: packaging component specifications, packaging component drawings, design history files (for combination products), project value stream mapping, and procedures for bulk and finished drug product. - Supporting primary packaging related regulatory filings. - Exposure on distribution testing, shipping studies, line trials, packaging material qualifications, child resistant requirements, human factor studies and patient centric designs. - Identification and validation of secondary and tertiary package materials and suppliers. - Project execution for harmonization/standardization, quality risk remediation/reduction, and continuous improvement projects. - Developing, tracking, and maintaining project plans allied to budgets for packaging related projects. - Originating and developing new packaging projects and initiatives that lead to process improvements & have a significant business impact. - Supporting sustainability / green packaging initiatives as per organizational requirement.Full time

About the Company

Piramal Pharma

CDMO and hospital generics, consumer health

Piramal Pharma is a diversified pharmaceutical group with three divisions: Piramal Pharma Solutions (PPS), Piramal Critical Care (PCC), and the Consumer Products Division (CPD). PPS operates as a contract development and manufacturing organization, providing development and manufacturing services across the drug lifecycle for clients in North America, Europe, and Asia through a globally connected network. PCC specializes in complex hospital generics, particularly inhaled anesthetics, serving markets in the USA, Europe, and over 100 countries. CPD leads consumer healthcare in India with brands such as Littles, Lacto Calamine, i-pill, Tetmosol, Polycrol, and Tri Activ, and the company serves pharmaceutical companies, hospitals, and consumers by leveraging its manufacturing scale and distribution network.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Maharashtra, India
Founded: 2020

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