Director, Validation

Director, Validation page is loaded## Director, Validation locations:
Bedford, NH, USAtime type:
Full time posted on:
Posted Todayjob requisition :
JR116515

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 clean rooms, 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.
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* 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.
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* 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, clean rooms, 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…