4 to 6 Years Relevant Experience
We are seeking a Pharma Package Component Development Engineer to lead and execute packaging development initiatives across primary, secondary, and tertiary packaging systems. This role requires hands-on expertise in component design, specification creation, SAP BOM management, and cGMP documentation, with the ability to work across functions in a regulated environment.
Screening Questions (Must Address in Application):
- Do you hold a relevant Packaging Degree or Certification?
- Do you have experience in Primary, Secondary, and Tertiary packaging component development?
- Have you worked on component design and specification creation?
- Are you experienced with copy and graphics specification development?
- Do you have experience working in SAP, especially Bill of Materials (BOM) creation and maintenance?
- Are you familiar with cGMP guidelines and documentation practices?
- Have you been involved in packaging validation, including line trials and protocol/report execution?
- Do you have hands-on experience with bottle and blister packaging systems?
Key Responsibilities:
- Plan and execute packaging engineering assignments related to lifecycle management and new product development.
- Lead development of material and structural design for packaging systems — Primary, Secondary, and Tertiary.
- Create and approve component drawings, copy/graphics specs, and finished put-up specs.
- Collaborate with R&D on component design, product changes, and technical documentation.
- Author and manage end-to-end packaging documentation, including:
- Package Development Assessments and Plans
- Component Specifications and Drawings
- Packaging Line Trial Protocols and Reports
- Final Development Reports
- Lead physical testing and validation to ensure packaging integrity from production through end-user.
- Troubleshoot and resolve packaging issues during manufacturing and post-market.
- Perform SAP data entry, including raw material code creation and BOM updates/revisions.
- Execute packaging validation, line trials, and ensure compliance with cGMP and regulatory standards.
Technical Qualifications:
- Strong understanding of Package Component Development and Specification Creation.
- Proficient in cGMP documentation practices.
- Experience with SAP, especially in BOM creation, component data entry, and change management.
- Familiarity with copy, graphics, pallet pattern design, and finished goods specs.
- Experience with bottle, blister, and other pharma packaging formats.
Skills & Competencies:
- Strong cross-functional collaboration skills (R&D, Marketing, Ops, Regulatory, Sales, etc.).
- Excellent project and program management abilities.
- Proficiency in Microsoft Office, especially Excel and PowerPoint.
- Effective communication, negotiation, and analytical skills.
- Strong business acumen and attention to process excellence.
- Six Sigma, Lean, or Process Excellence certification is a plus.
Preferred Qualifications:
- Degree in Packaging Engineering, Pharmaceutical Sciences, Mechanical Engineering, or related field.
- Prior experience in the pharmaceutical or healthcare industry.
- Experience with regulatory packaging requirements in FDA, EMA, or ICH regulated environments.