Director, Validation

PCI Pharma Services•Bedford, NH

About The Position

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. 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.

Requirements

Bachelor’s degree in science or engineering required.
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).
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.

Nice To Haves

A master’s degree is a plus, preferred.
Experience with Process Validation as a plus.

Responsibilities

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.