Validation Lead – Pharma (Sterile Injectables)

Job Title: Validation Lead – Pharma (Sterile Injectables)

Location: Fall River, MA(On-site)

About The Role

We are seeking a Validation Lead to drive validation strategy and execution within a sterile pharmaceutical manufacturing environment. This role requires hands-on ownership of IQ/OQ/PQ protocol authoring and execution, along with strong experience in cGMP compliance, change control, and audit readiness.

Key Responsibilities

Lead end-to-end validation lifecycle activities (planning → protocol authoring → execution → reporting)
Independently author and execute IQ/OQ/PQ protocols for equipment, utilities, and processes
Ensure compliance with cGMP, FDA, and regulatory requirements
Support sterile manufacturing processes (vials, prefilled syringes, IV bags)
Manage change control, deviations, and CAPA in a regulated environment
Collaborate with Quality Assurance, Manufacturing, Engineering, and Regulatory teams
Support internal and external audits, including FDA inspections
Drive risk assessments and validation strategies for new and existing systems
Maintain accurate validation documentation and reports
Participate in CapEx projects related to equipment and facility upgrades
Ensure all validation activities meet quality, safety, and compliance standards

Must-Have Requirements (Strict Screening)

Bachelor’s degree in Engineering (Mechanical, Electrical, or related field); Master’s preferred
5+ years of experience in pharmaceutical or biotech validation (mandatory)
Hands-on experience in sterile injectables manufacturing (vials / PFS / IV bags)
Independent IQ/OQ/PQ protocol authorship and execution (must-have)
Strong experience with validation lifecycle documentation
Proven experience handling change control, deviations, and CAPA
Experience supporting regulatory audits (FDA/cGMP environment)

Good to Have

PMP certification
Experience with SAP or validation/project management tools
Exposure to CapEx project execution and cross-functional coordination

Skills: protocol,validation,manufacturing
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