Validation/Sterilization Manager

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Summary of Objective:

Validation/Sterilization Manager is responsible for qualification, validation, and lifecycle management of terminal sterilization equipment and processes. This includes bioburden environmental monitoring and sterility assurance strategy. The position is also responsible for utilities/facilities qualification and temperature mapping.

• Develops and maintains associated Validation Master Plans, Standard Operating Procedures, Work Instructions, as well as other applicable documentation.
• Interacts with customers and the PCI Philadelphia site to ensure that the sterilization process is validated in compliance with product requirements and applicable industry standards.
• Ensures that any sterility assurance strategy provides appropriate risk-mitigation in the stepwise reduction of bioburden.
• In charge of defining and maintaining the sterilization processing categories and the product families.
• SME supporting change management and maintaining the qualified/validated state of sterilization equipment and processes.
• Communicates with other departments regarding validation planning and coordinates resources for protocol execution.
• Collaborates with the site commercial Validation Manager for any validation overlap.
• Assures regulatory and any applicable customer requirements are accurately incorporated into PCI systems and assures validation documentation adheres to cGMP requirements.

Essential Duties and Responsibilities:

• Manage Quality Management System elements necessary to ensure appropriate characterization of the sterilizing agent, development, validation, and routine monitoring and control of the terminal sterilization process. This includes strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex 15, Qualification, Validation and Life Cycle Management requirements.
• Provides leadership and coaching in terminal sterilization of devices, bioburden control, and sterility assurance.
• Direct interface and support for strategic device sterilization accounts.
• Mentoring and/or training in technical elements of validation (e.g. Risk Analysis, MSA and DOE) and sterilization process (e.g. dose mapping, dosimeter placement, product-to-sterilizer orientation, etc.).
• Responsible for sterilization dose mapping activities for new products or changes to existing products.
• Support routine terminal sterilization operations. Responsible for the site Environmental Monitoring program.
• Responsible for the site Temperature Mapping program. Develop and maintain the PCI PHL Site Validation Master Plan for terminal sterilization of devices.
• Develop and maintain the PCI PHL Site Validation Master Plan for utilities/facilities.
• Develop, approve, and execute Validation Lifecycle Documentation.
• Support and influence change management on site: Liaison between Validation Core Team, PCI Business Unit Program Managers, Site Leadership Team and PCI PHL Customer Programs. Participate in site quality management reviews and reports on Validation status.
• Drives continual improvement to foster a culture of quality that permeates all levels of the organization. Ensures compliance and regulatory readiness.
• Supports regulatory inspections and customer audits. Manage, identify, hire, and develop staff.
• Create and maintain employee and organizational development. Oversee proper training, goal setting and effective organizing and assigning of work.
• Support validation harmonization among sites across the PCI Pharma Services organization.
• Provide Validation technical expertise and guidance. Develop and administer budgets, schedules and performance evaluations.

Required:

• Bachelor or Technical equivalent degree in Chemical Engineering, Mechanical Engineering, Chemistry, Microbiology or similar science field.
• Terminal sterilization experience with one or more standard methods (irradiation, steam, ethylene oxide) or novel methods (nitrogen dioxide, hydrogen peroxide, dry heat).
• 7 years combined Quality, equipment qualification, and process validation process experience..
• 5 years of experience in terminal sterilization validation and sterility assurance with heavy emphasis in sterilization competency and validation strategy.
• 5 years of experience with medical device, combination device, or other regulated industries.
• Strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex 15, Qualification and Validation requirements.
• AAMII - Certified as an Industrial Sterilization specialist preferred.
• Environmental monitoring and sterility assurance is a plus.
• Critical utilities/facilities qualification is a plus.

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.