Manager, Facilities & Software Validations

Summary Of Objective

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. This role involves designing, maintaining, and continually improving the validation system, ensuring compliance with cGMP requirements, and providing technical expertise and guidance.

Essential Duties and Responsibilities

• Oversees and manages Validations Supervisor(s), engineers, and, as required, other Validations personnel
• Create and maintain employee and organizational development
• Review and approve validation and change control documentation, including protocols, summary reports, etc., for validation activities, process parameters, and validation work practices
• Manage and develop facility, utility, and computer validations program that is in compliance with regulatory and customer expectations, which includes developing and maintaining Validation Master Plan and policy and work practices
• Design, maintain and continually improving the validation system in line with current national and international standards
• Aid with validation harmonization among sites across the PCI Pharma Services organization
• Provide Validation technical expertise and guidance to the groups within the organization and customers on validation policies and procedures and the implementation of those within the Operations and Quality Assurance (QA) functional areas
• Develops and administers budgets, schedules and performance requirements and evaluations
• Plan, execute, and oversee validation of facilities, cleanrooms, and utilities (HVAC, compressed air, water systems, gases)
• Develop and approve validation documentation including URS, risk assessments, IQ, OQ, PQ, and validation 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 GAMP 5, 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+) are applied across computerized systems
• Serve as a risk management representative on cross-functional and multi-site teams to support integrating risk management into various product quality systems such as Change Control and CAPA
• Participate, present and provide rationale for the validation program during periodic audits and regulatory inspection and customer visits/conference calls as required

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related technical discipline
• Minimum of 6-8 years of experience in facilities, utilities, and computer system validation in a regulated industry (medical devices, pharmaceutical, or biotechnology)
• Prior experience supervising or leading validation personnel preferred
• Strong understanding of validation lifecycle activities (URS, risk assessments, IQ, OQ, PQ, and validation reports)
• In-depth knowledge of Computer System Validation (CSV) and GAMP 5 methodology
• Working knowledge of FDA regulations (21 CFR Parts 820, 210/211, and 11)
• 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
• 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 set and achieve challenging goals

Pay

$108,960.00 - $122,580.00 plus eligibility for an annual performance bonus

Benefits

PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).