Manager, Facilities and Metrology

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Manager, Facilities and Metrology is a key leadership role responsible for ensuring that all facility systems, critical utilities, and process and laboratory instrumentation remain in a validated state of control and in full compliance with cGMP and GDP requirements. This position provides strategic and operational leadership to a multidisciplinary technical team, integrating facility operations, calibration, and instrumentation management into a cohesive, highperforming function. The Manager ensures that all systems essential to sterile pharmaceutical manufacturing-including pure steam, WFI, purified water, HVAC, chillers, filling lines, lyophilizers, autoclaves, nitrogen and clean compressed air systems, as well as analytical and microbiology laboratory equipment-are maintained to the highest standards of reliability, safety, and regulatory compliance.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Ensures all aspects of facilities and metrology are adhering to cGMPS and PCI's established SOPs.
• Make the necessary recommendations and changes to improve process efficiencies.
• Ensures all projects are executed safely, on time, and within budget.
• Responsible for all aspects of facilities and calibration programs.
• Oversee the departmental budget and headcount
• Provides coaching, mentoring and development to each direct report both in execution of their group responsibilities and in their own development.
• Provides leadership to ensure facilities and calibration supports manufacturing operations in a fashion that focuses on quality and adherence to the schedule in support of Operations
• Assures compliant and timely completion of all quality documents (Deviations, CAPAs, Change Controls, etc.) assigned to the facilities and calibrations team.
• Support a variety of regulatory and client audits.
• Ensures team training and performance compliance with all corporate policies and procedures.
• Provides guidance to people managers in the areas of compliance, safety, deviations, corrective and preventive actions, and investigations related to facilities and calibration areas.
• Works closely with key functions such as Quality, Manufacturing, EH&S, Sales/Project Management, Engineering, and Global PMO to ensure internal and external clients' requirements are met.
• Analyzes existing processes/unit operations and determines modifications necessary to improve safety, as needed and streamline processes.
• Responsible for on time calibration schedules for Madison site.
• Advanced knowledge and understanding of PLC programming and integration that support GMP automated system, vial transport equipment, clean utilities, sterilization equipment, and lyophilizers.
• Direct assigned personnel, including performance evaluations, scheduling, orientation and training. Recommends employee hires, transfers, promotions, salary changes, discipline, termination and similar actions, as appropriate.
• Maintains the professional competence, knowledge and skills necessary for the satisfactory performance of all assigned responsibilities.
• Provides leadership in analyzing and developing improvements in process efficiency, quality, safety and client relationships (internal and external).
• Correctly implements industry best practices that will successfully withstand regulatory inspections by regulatory authorities

QUALIFICATIONS:

Required:

• 5+ years of experience in the field of technical facilities or metrology in the biopharma/pharm and/or medical device facilities and proven leadership experience.
• Bachelor's degree in engineering, chemistry, biology, or related technical discipline or equivalent combination of work experience and schooling/certifications.
• Preferred 3+ years management/leadership experience.
• Operational background in cGMP environment, preferably in aseptic manufacturing / facilities.
• Demonstrated skill in managing a diverse population of professional, technical, and hourly personnel as well as external resources.
• Experience with direct exposure to Customers in a CDMO business is a plus.
• Demonstrate commitment to continuous improvement at all levels within the organization.
• Excellent organizational skills
• Experience in the Management of 5+ people

Preferred:

• Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines
• Excellent verbal and written communication skills
• Ability to effectively manage multiple projects, teams and technical staff at all levels
• Ability to assess and develop organizational talent which includes engaging employees and driving technical and personal development. Setting future leadership for success.
• Performance measurement and KPI Tracking and Reporting
• Proficiency with MS Office suite is preferable.
• Leads by example to motivate and engage through clear communication, of vision and goals.
• Demonstrates resilience and takes a proactive approach to change management to enable leaders to drive the change successfully.
• Effective verbal and written communication with both internal and external contacts is critical to success
• Set a clear vision and direction for the reporting functions, encouraging communication and a team-based approach.

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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.