Director, Validation
Company: PCI Pharma Services
Location: Bedford
Posted on: April 1, 2026
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Job Description:
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. 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. LI-AL1 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.
Keywords: PCI Pharma Services, Chelsea , Director, Validation, Engineering , Bedford, Massachusetts
