Sterilization Manager - Validation, Sterility Assurance, and Utilities/Facilities

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Job Title: Sterilization Manager - Validation, Sterility Assurance, and Utilities/Facilities

Department/Group: Quality / Validation

Location: Philadelphia

Reports to: Director, Validation

FLSA Status: Exempt

Prepared By: Dennis Gerlach

Approved By: Nancy Dorr

Summary of Objective:

Validation Manager - Sterilization, Sterility Assurance, and Utilities/Facilities 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: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

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. Knowledge of and adherence to PCI policies and procedures. Attendance to work is an essential function of this position. Act as back up to site Validation Manager - Commercial. Performs other duties as assigned by Director.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

• Stationary Position: From 1/2 to 3/4 of the day.
• Move, Traverse: Up to 1/4 of the day.
• Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.
• Install, place, adjust, apply, measure, use, or signal: None.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): None.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: Up to 1/4 of the day.

On an average day, the individual can expect to move and/or transport up to 10 pounds

less than 1/4 of the day.

This position may have the following special vision requirements.

• Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception
• Ability to focus No Special Vision Requirements

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• Work is primarily performed at a desk and/or in an office environment. for 1/2 to 3/4 of the day.
• The noise level in the work environment is typically, quiet.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor or Technical Equivalent Degree in Engineering, Microbiology or Science field.
• 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.
• Terminal sterilization experience with Ethylene Oxide (EtO), Vaporized Hydrogen Peroxide (VHP), and/or Nitrogen Dioxide (NO2).
• Quality System Management experience.
• Process Development experience.
• Demonstrated knowledge of analytical and statistical tools (e.g. Minitab, Advanced MS Excel capabilities)
• Green Belt / Black Belt on Six Sigma Training is a plus.
• Ability to lead or participate in Root Cause Analysis and Risk Management exercises (e.g. FMEA)

OTHER SKILLS & CHARACTERISTICS:

• Works independently with minimal guidance.
• Usually determines own work priorities.
• Acts as a resource and mentor for colleagues with less experience
• Statistical and Advanced Mathematical Skills
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
• Supervisory Responsibilities
• High Standard of Report Writing

Preferred:

• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to display original thinking and creativity.
• Ability to show success in managing employees.
• Ability to demonstrate attention to detail.

Ability to set and achieve challenging goals.

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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, Diversity, Equity, and Inclusion (DEI) 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.