Manager - Packaging Technology

2+ years

Not Disclosed

Navi Mumbai

10 Oct. 29, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Packaging Development Engineer

Business: Piramal Critical Care
Department: Packaging Technology
Location: Rabale, Navi Mumbai
Travel: Medium

Job Overview

We are seeking a Packaging Development Engineer to lead various packaging projects at Piramal Critical Care. This role involves collaborating with cross-functional teams to develop, test, validate, and commercialize packaging solutions and medical devices for both new and existing products. You will also support continuous improvement initiatives and address redesign needs for marketed products. Key responsibilities include new product development, preparing technical documentation for regulatory files (e.g., FDA 510k and CE mark), performance analysis, risk management, and design transfer to manufacturing.

Key Stakeholders

Internal: Supply Chain, R&D, Quality Assurance, Regulatory Affairs, Manufacturing
External: Vendors, Consultants

Reporting Structure

Reports to: Chief Manager – Packaging Technology

Relevant Experience

Bachelor’s degree with 10-15 years of experience in the pharmaceutical (preferably sterile products) or medical device industries.
Proven experience in developing primary container designs and specifications, as well as supporting primary packaging-related regulatory filings.
Strong project management skills within Packaging and/or Engineering.
Experience writing technical documentation for regulatory files (e.g., FDA 510k and CE mark).
Deep understanding of global regulations regarding packaging and medical device regulations.

Key Responsibilities

Design packaging systems and medical devices for anesthetic drug products, including materials for primary, secondary, and tertiary packaging.
Support development of adaptors, integrated closures, kits, and vaporizers.
Develop 3D CAD & SolidWorks models, including engineering drawings for products and components.
Collaborate with manufacturing, supply chain, and logistics teams to identify challenges and improvement opportunities.
Leverage 3D printing and additive manufacturing for prototyping and low-volume production.
Conduct stability studies, machine feasibility studies, packaging trials, and regulatory filings.
Prepare usability and human factor test protocols, conduct testing, analyze results, and write reports.
Maintain Design History Files and prepare technical documentation for regulatory submissions.
Create and improve Design Control and Quality Management System procedures in collaboration with Quality and Regulatory teams.
Conduct root cause analyses and implement corrective/preventive actions.
Develop and maintain project plans aligned with budgets for packaging-related projects.
Initiate new packaging projects that lead to process improvements and have a significant business impact.
Support sustainability and green packaging initiatives as per organizational requirements.

Key Competencies

Knowledge of packaging materials, processes, and technologies, including medical devices.
Understanding of industry standards and regulatory guidelines related to packaging.
Proficiency in identifying issues and developing solutions in packaging design and processes.
Ability to manage multiple projects, timelines, and stakeholders effectively.
Excellent interpersonal skills for working with cross-functional teams.

Qualifications

Essential:

BS in Mechanical Engineering or Graduate in Packaging Technology with strong expertise in medical device development and R&D product packaging development.

About Us

Piramal Group has pursued a twin strategy of organic and inorganic growth for over three decades. Driven by core values, we aim for inclusive growth while adhering to ethical practices.

Equal Employment Opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based on race, ethnicity, religion, gender, sexual orientation, age, or any other legally protected characteristic.

About the Team
Piramal Critical Care (PCC) is a global leader in inhaled anesthetics and hospital generics, committed to delivering critical care solutions worldwide. With a workforce of over 400 employees across 16 countries, PCC is focused on expanding its global footprint through new product additions in critical care.

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