Manager, Facilities & Software Validations

Facilities and Software Validations Manager

The Facilities and Software Validations Manager is responsible for coordinating and managing all validation efforts related to Facility/Utility and Computer Equipment at multiple facilities. The Validations Manager is responsible for designing, maintaining and continually improving the validation system. The Validations Manager is responsible for implementation and ongoing improvements of the validation policies, protocols and testing. Provide technical expertise and guidance to customers, the Validations department as well as working with the range of internal departments.

Coordinate with other departments to communicate validations and provide resources to implement protocol executions. The Facilities and Software Validations Manager assures customer requirements are accurately incorporated into PCI systems and assures validation protocols adhere to cGMP requirements.

• Oversee and manage Validations supervisors, engineers, and other validation personnel; manage hiring, development, training, goal setting, and work organization.
• Review and approve validation and change control documentation, including protocols, summary reports, and work practices.
• Manage and develop facility, utility, and computer validations program to comply with regulatory and customer expectations; develop the Validation Master Plan, policies, and work practices.
• Design, maintain and continually improve the validation system in line with current national and international standards; assist with validation harmonization across sites.
• Provide validation technical expertise and guidance to internal groups and customers on policies, procedures, and implementation within Operations and QA.
• Administer budgets, schedules, performance requirements, and evaluations.
• Plan, execute, and oversee validation of facilities, clean rooms, and utilities (HVAC, compressed air, water systems, gases).
• Develop and approve validation documentation including URS, risk assessments, IQ, OQ, PQ, and summary reports.
• Ensure facility changes are evaluated through change control and revalidation activities as required.
• Support environmental monitoring programs and facility qualification strategies.
• Lead CSV activities in accordance with GAMP5, FDA, and ISO requirements; define validation strategies based on system impact, intended use, and risk.
• Review and approve system lifecycle documentation (URS, FS, DS, risk assessments, test scripts, traceability matrices).
• Ensure data integrity principles (ALCOA+) across computerized systems.
• Serve as a risk management representative on cross‑functional and multi‑site teams to integrate risk management into product quality systems such as Change Control and CAPA.
• Participate, present, and provide rationale for the validation program during periodic audits, regulatory inspections, customer visits, and conference calls.
• Work overtime or weekends as required.

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.
• Minimum 6–8years of experience in facilities, utilities, and computer system validation in a regulated industry (medical devices, pharmaceuticals, or biotechnology).
• Advanced computer skills and ability to perform complex computer tasks.
• Experience supervising or leading validation personnel (preferred).
• Strong understanding of validation lifecycle activities (URS, risk assessments, IQ, OQ, PQ, reports).
• In‑depth knowledge of CSV and GAMP5 methodology.
• Working knowledge of FDA regulations (21
  
  CFR Parts
  820, 210/211, and
  11).
• Full professional proficiency in written and spoken English at all professional levels.
• Strong reasoning, report writing, problem‑solving, creativity, employee management, attention to detail, and goal‑setting skills.

Hiring rate: $108,960 – $122,580 plus an annual performance bonus. PCI offers a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

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.