Validation Manager

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 Validation Manager for Facilities, Utilities, Systems, Equipment in the validation department is responsible for performing the qualification activities to ensure the Facilities, Utilities, Systems, and Equipment within all New Hampshire manufacturing facilities remain within a qualified/ validated state. This role will collaborate with Engineering, MTS, QC, MFG and Quality to deliver robust and efficient qualification and/or validation. The function also provides daily support to all manufacturing enabling teams as a Subject Matter Expert (SME) in Facilities, Utilities, Systems, and Equipment (FUSE) validation for PCI Medical Device and Drug manufacturing. The manager will drive the FUSE validation strategy and project deliverables for multiple projects at all PCI New Hampshire facilities. The manager will ensure adherence to internal procedures /quality guidelines and external regulatory requirements. The Validation Manager will be responsible for representing FUSE during Client Audits and Regulatory inspections. 

Essential Duties and Responsibilities:

• Work, at all times, in a safe manner in full adherence to PCI EHS guidelines and policies.  
• Support cGMP manufacturing operations for clinical, commercial and medical devices. 
• Responsible for the day-to-day Equipment, Utilities and Facility validation support. 
• Establish/Maintain Validation plans and procedures for sterilization, cleaning, environmental monitoring, Utilities qualification. 
• Ensure PCI policies meet or exceed industry and regulatory guidelines. 
• Provide technical assessments on change controls, deviations and investigations, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status.  
• Establish and implement quantifiable performance metrics (KPI’s) to plan, track and report on validation departmental performance against goals and objectives. 
• Manage the FUSE validation team and ensure that the team meet deliverables. 
• Develop the validation team by coaching and mentoring team members, enabling them to be efficient; productive and engaged. 
• Provide front room and backroom support for client audits and regulatory audits. 
• Defends FUSE policies, procedures and protocols. 
• Provide audit responses in a timely manner and meet all client and regulatory commitments  
• Establish/Maintain site good practices (user requirement specifications, Equipment Impact assessments, engineering/design specifications, risk assessments, etc.) 
• Author validation plans, URS, EIA, ERES documents, SAT and FAT protocols and reports as well as IQ/OQ/PQ/ RQ protocols, test scripts, and reports.  
• Develop, execute and document risk assessments and evaluations to determine testing strategies  

EXPERIENCE

• Demonstrated successful experience as a manager of technical personnel (3 – 5 years preferred) 

• Experience planning, organizing, and coordinating work of validation engineers.  

• Strong working knowledge of regulatory requirements for Cleaning Validation, Sterilization, Lyophilization, and Aseptic Filling lines/ equipment. 

• Prior experience authoring and executing SAT, FAT, IQ, OQ, PQ, and RQ protocols and summary reports. 

• Working knowledge of risk assessment methodologies and practices including prior experience using risk analysis for testing strategy development and justification. 

PROFESSIONAL SKILLS

• Fully developed leadership skills to inspire and motivate team members in a creative and effective manner 

• Excellent communication (verbal and written) and inter-personal skills coupled with the ability to problem solve, provide leadership support and strategic direction.

• Demonstrated ability to collaborate with multiple functions to coordinate the execution of validation activities and incorporate validation results into routine operational practices.  

• Microsoft Office and Computer skills required (Excel, PowerPoint, and word processing) 

QUALITIES

• Self-motivated with a drive for quality and excellence 
• Ability to meet timelines, work in demanding, high pressure, fast paced environment with ability to seamlessly transition between priorities
• High attention to detail and adherence to regulatory guidelines

• Creative and able to work with minimal supervision following internal procedures balanced with independent thinking and judgement 

• Positive attitude and strong interpersonal skills. Resilient through operational and organizational change 

•  Honesty, integrity, respect and courtesy with all colleagues   

PHYSICAL REQUIREMENTS & MENTAL DEMANDS 

• Ability to lift 50 pounds 

• Able to don cleanroom gowning and PPE, as required by site procedures. 

• The ability to work at all PCI site locations/Facilities.  

COMMUNICATIONS & CONTACTS

• Interacts with all departmental staff and maintain a professional, courteous, respectful relationship with internal cross-functional teams; maintain a positive feedback. 

• Maintain a professional, courteous, respectful relationship with external and internal cross-functional teams; maintain positive feedback. May occasionally support off shift activities. 

MANAGERIAL & SUPERVISORY RESPONSIBILITIES

Manage FUSE team

TRAVEL

Potential for up to 10 - 15% 

Qualifications:

EDUCATION  

BS in Engineering or related Life Sciences with a minimum of (12+) years relevant experience or MS in related field with a minimum of 8+ years relevant experience preferably within a GMP manufacturing (aseptic/sterile product facilities) environment or equivalent experience. 

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.