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.
- Corporate Sterility Assurance Roadmap: Develop and execute a multi-year strategic roadmap for sterility assurance that aligns with PCI's growth in advanced drug delivery and sterile manufacturing.
- Global Aseptic Standards: Author and maintain global quality standards for aseptic processing and sterility operations, ensuring harmonized practices across all sites that leverage industry best practices (e.g., PDA TRs, ISPE).
- Center of Excellence (CoE): Establish a Global Sterility Assurance Center of Excellence to serve as the central repository for technical expertise, troubleshooting, and innovation in microbiological control.
- Contamination Control Strategy (CCS): Lead the development and technical oversight of Site-Specific Contamination Control Strategies for all sterile facilities, ensuring compliance with EU GMP Annex 1.
- Non-Sterile Bioburden Reduction: Implement a stepwise bioburden reduction program for non-sterile manufacturing sites, focusing on risk-based environmental controls and prevention of objectionable organisms.
- Clean Utility Governance: Establish global standards for the sterile sampling and microbiological monitoring of clean utilities (WFI, Purified Water, Clean Steam, and Compressed Gases).
- Laboratory Standardization: Co-establish best practices with site Microbiology Labs for Environmental Monitoring (EM) and Personnel Monitoring (PM), ensuring data integrity and standardized incubation/identification protocols.
- Advanced Monitoring Technologies: Evaluate and implement rapid microbiological methods (RMM) and automated EM data collection tools in collaboration with the eCompliance and Digital Transformation teams.
- Disinfectant Qualification: Standardize global programs for disinfectant efficacy testing (DET) and site-specific cleaning/sanitization validation.
- Curriculum Development: Design and deploy comprehensive sterility assurance education and training programs for operators, engineers, and quality personnel.
- Microbiologist Development: Train and mentor site Industrial Microbiologists to serve as "Shop Floor Champions," moving the role from a laboratory-based function to an active, real-time presence in the manufacturing suite.
- Aseptic Technique & Behavior: Oversee global programs for aseptic gowning qualification and media fill (Process Simulation) design, focusing on the psychological and behavioral aspects of cleanroom discipline.
- Capital Project Support: Provide expert technical consultation for new builds and retrofits, ensuring facility design, airflow patterns (Grade A/ISO 5), and equipment sterilization (SIP/Autoclave) meet global regulatory expectations.
- Regulatory SME: Serve as the primary Subject Matter Expert for Sterility Assurance during high-stakes regulatory inspections (FDA, EMA, MHRA), defending CCS and sterility strategies.
- This position may require extra hours and/or weekend work.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
- Attendance to work is an essential function of this position
- Performs other duties as assigned by leadership.
Supervisory Responsibilities: Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Supervises 1-10 employees
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:- Education: Bachelor's degree in Microbiology, Biology, or a related Life Sciences discipline required; Master's degree or PhD in Microbiology preferred.
- Experience: * Minimum of 12-15 years of experience in Sterility Assurance or Industrial Microbiology within a GxP pharmaceutical environment.
- Proven expertise in EU GMP Annex 1, USP /, and ISO 14644 standards.
- Extensive experience in sterile fill-finish operations, lyophilization, and terminal sterilization.
- Track record of establishing global programs or Centers of Excellence.
- Leadership: Exceptional teaching and mentoring skills; ability to influence site-level culture and drive technical excellence through collaboration with MS&T and Global Engineering.
- Bachelor's Degree in a related field and/or 10+ years related experience and/or training.
- College Level 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.
- Ability to Travel
Preferred:- Master's Degree (M.A.) in related field and/or 5+ years related experience or training.
- Ability to work independently and/or part of a team.
- Ability to effectively present information to various people as the job requires.
- Ability to identify and resolve problems in a timely manner.
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