Director, Validation

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Summary of Objective:

As a member of the Validation organization, the Validation Director will lead pharmaceutical and medical device validation operations and staff across all PCI sites. The scope of responsibility encompasses all planning and implementation of drug and medical device overall validation activities, including computer systems, in a CMO aseptic fill finish environment and ensure the proper validation of all equipment and processes. The Validation Director will also schedule the appropriate resources for assistance with validation, to meet the established production schedule, vendor/contract activities in the cleanrooms, maintain a state of control within the cleanroom environment, and support facilities and other operations, development and maintenance of validation program documents including SOPs, Validation Project (VPP) and Validation Master (VMP) Plans. This individual should be able to manage tasks and responsibilities with minimal guidance and demonstrate outstanding multi-tasking, problem solving and communication skills, in a dynamic and challenging contract manufacturing environment.

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.

• Provide strategic and operational leadership to the Validation function, ensuring continuous, compliant execution of validation activities in alignment with established procedures, schedules, and business objectives.

• Evaluate process, equipment, and systems validation capabilities across Operations and develop short- and long-term improvement strategies to support corporate and regulatory goals.

• Guide the strategy for development, execution, review, and approval of all validation documentation, including IQ, OQ, and PQ protocols and reports.

• Ensure effective oversight of change control, deviations, investigations, and CAPAs related to validation activities; provide leadership in Quality Management System (QMS) integration and inspection readiness.

• Partner with senior leadership to define and implement validation strategies for new and existing processes, equipment, utilities, and systems, translating strategy into compliant protocols and SOPs.

• Direct and manage all aseptic and non-aseptic validation activities, including process validation, cleaning validation, sterilization validation, and equipment qualification.

• Maintain ownership and accountability for the site Master Validation Plan, ensuring alignment with regulatory expectations and business needs.

• Serve as a primary client and internal stakeholder interface for assigned validation projects, ensuring alignment on scope, timelines, and compliance requirements.

• Provide strategic leadership for validation-related regulatory inspections and third-party audits, including timely and effective closure of observations and commitments.

• Interface with regulatory agencies during inspections and technical discussions, representing the organization's validation strategy, rationale, and compliance posture.

• Lead project planning, prioritization, and resource allocation for validation teams to ensure timely execution of validation initiatives.

• Mentor, develop, and evaluate validation staff, fostering a culture of collaboration, technical excellence, and sustained cGMP compliance.

• Perform additional duties as assigned in support of operational excellence and evolving business needs.

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.

• Bachelor's degree in science or engineering required.

• A master's degree is a plus, preferred.

• 15+ years of progressive leadership of operational validation experience in Pharmaceutical or Biotechnology industry, required.

• Sound industry knowledge of pharmaceutical and medical device facilities, lyophilization technology, cleanrooms, facilities clean utilities. WFI, purified water, process gasses, HVAC and industry processes and utilities

• Experience in successful management of complex technical issues using structured analysis, methodology and articulates clear and concise direction to other operations staff

• Strong experience with project and people management, particularly for large validation projects or programs

• Experience in Facility, Equipment and Utility or Cleaning validation is a must (preferably in a multi-product CMO facility). Experience with Process Validation as a plus.

• Demonstrate SME level knowledge of process/equipment validation, computer systems, standards and GxP regulations. Strong technical experience in the successful management of complex validation is required

• Able to effectively lead and coordinate multiple, complex requests/projects and allocate resources effectively, across multiple sites, managing both local and remote based staff

• Advanced understanding of applicable regulatory requirements (FDA, EMA, international regulatory)

• Audit experience is strongly preferred

• Advanced understanding of industry standards for commissioning and validation of facilities, utilities and process equipment for cGMP manufacturing

• Strong oral and written (reports) communication, organization and leadership skills

• Responsible for the activities and schedules to meet designated timelines as well as communicating with the technical team on technical aspects of the processes, if needed.

• Responsible for communicating the status of validation activities with Operational Management, Project Management, MTS, Facilities, Engineer, Material Management, EHS and Quality teams.

• The Director will participate in audits from clients and Regulatory agencies, as appropriate.

• Responsible for directing activities of Validation team members

• Responsible for the staff's development and preparation of staff evaluations

• Must be able to provide hands-on leadership, coaching and coordination of needed actions with a focus on achieving production goals.

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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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled