Validation Lead

3 weeks ago

Bedford, Massachusetts, United States iPharm Full time
Job Title: Lead Validation Engineer

We are seeking a highly experienced Validation Lead to join our team at iPharm, a global leader in joint health therapies and regenerative medicine. The ideal candidate will have a proven track record of leading validation projects, developing validation strategies, and managing cross-functional teams.

Key Responsibilities:
  • Technical Leadership: Lead and manage validation activities, including equipment, utilities, manufacturing, and packaging.
  • Validation Strategy: Develop and oversee the overall validation strategy, ensuring alignment with GMP requirements and regulatory expectations.
  • User Requirement Specifications (URS): Collaborate with manufacturing, engineering, facilities, quality, and regulatory teams to develop comprehensive URS.
  • IQ/OQ/PQ & Process Validation (PV): Oversee and ensure successful completion of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new equipment and utilities.
  • Risk-Based Approach: Implement a risk-based validation methodology to streamline testing and documentation requirements.
  • Master Validation Plan (MVP): Develop, implement, and manage the Master Validation Plan. Coordinate with internal teams, contractors, and vendors.
  • Documentation & Compliance: Ultimately responsible for all validation protocols, reports, and supporting documentation to ensure compliance with regulatory standards.
  • Cross-functional Collaboration: Engage with senior stakeholders across multiple functions (engineering, quality, regulatory, etc.) to ensure validation activities are aligned with broader project goals.
Qualifications:
  • Experience: Years of experience in a validation role within a GMP pharmaceutical and/or medical device aseptic/sterile fill/finish environment.
  • Leadership: Proven leadership experience, managing validation projects and leading cross-functional teams.
  • Technical Expertise: In-depth knowledge of validation requirements for equipment, utilities, and processes within a GMP-regulated environment.
  • Regulatory Compliance: Strong understanding of regulatory expectations (e.g., FDA, EMA, ISO standards) as they relate to validation activities.
  • Project Management: Ability to manage complex projects with multiple stakeholders and deliver on time.
  • Risk-Based Validation: Experience implementing risk-based validation approaches.
  • Documentation Skills: Strong experience in writing and reviewing validation protocols, reports, and related documents.
Preferred Qualifications:
  • Experience with sterile fill/finish processes in a pharmaceutical or medical device environment.
  • Experience with both small molecule and biological drug manufacturing validation is a plus.

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