SUMMARY: The Sterile Packaging Manager leads and oversees sterile packaging and sterilization activities. This role partners cross-functionally with Regulatory, Product Development, Operations, Supply Chain, and Quality to develop and execute sterile packaging strategies from concept through commercialization and post-market support. Serving as an organizational subject matter expert, this position ensures sterile packaged products meet requirements for sterility assurance, packaging integrity, shelf life, transportation, distribution, and regulatory compliance.
The Sterile Packaging Manager provides leadership for packaging design and development, validation strategy, process controls, and technical documentation, including Design History File (DHF) requirements. The role establishes procedures and standards related to sterile packaging, sterilization, cleanroom monitoring, and biocompatibility while leading continuous improvement initiatives and developing team members and cross-functional project teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)
- Lead the strategy, development, implementation, and lifecycle management of sterile packaging designs across product lines in partnership with product development teams to ensure packaging, labeling, and sterilization requirements are achieved.
- Direct sterile packaging and sterilization activities for new product introductions, design changes, and sustaining engineering initiatives.
- Oversee the design, evaluation, and approval of packaging components and sterile packaging systems for medical device products.
- Review, approve, and maintain packaging, labeling, and related technical documentation to ensure compliance with applicable requirements.
- Lead risk assessment activities related to product, packaging, sterilization, and process changes to maintain sterility assurance and package integrity across all applicable entities.
- Establish validation strategies and oversee execution of sterile packaging-related validation and verification activities, including sealing validations, OQ/PQ studies, design of experiments, transit testing, aging studies, sterilization validations, and ongoing process monitoring.
- Ensure effective monitoring, control, and continuous improvement of sterile packaging processes across internal and external manufacturing locations.
- Develop and maintain procedures, business processes, work instructions, and training programs related to sterile packaging and sterilization activities.
- Provide leadership and technical oversight for creation and approval of protocols, reports, technical justifications, and validation documentation.
- Ensure packaging and sterilization validation programs remain current, effective, and compliant at all applicable facilities.
- Lead design transfer activities and ensure critical process parameters are defined, documented, transferred, and controlled based on process capability and risk.
- Partner with Operations to optimize sterile packaging equipment, manufacturing processes, and production readiness while providing technical consultation to contract manufacturing partners and customers as needed.
- Manage sterile packaging project timelines, priorities, and resource allocation to support business objectives and product launch commitments.
- Lead investigations and corrective actions associated with post-market surveillance signals, nonconformances, and quality events related to sterile packaging.
- Represent sterile packaging and sterilization functions during customer, internal, regulatory, and certification audits.
- Supervise, coach, and develop assigned team members and provide leadership to cross-functional project teams.
QUALIFICATION REQUIREMENTS:- Bachelor's degree in Packaging Engineering, Packaging Science, Engineering, or related technical discipline.
- Minimum 5-7 years of progressive experience in sterile packaging within medical device, pharmaceutical, or related regulated industry; medical device experience strongly preferred.
- Previous experience leading projects, initiatives, teams, or direct reports preferred.
OTHER SKILLS and ABILITIES:- Strong leadership, project management, and cross-functional collaboration skills.
- Knowledge of applicable standards including ISO 11607, ISO 11137, relevant ASTM standards, and quality system requirements.
- Experience with manufacturing processes, process validation, statistical analysis, and risk management methodologies.
- Ability to influence decision-making and drive execution across multiple stakeholders and facilities.
