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Lead Validation Engineer

2 months ago

Bedford, United States i-Pharm Consulting Full time

Lead Validation Engineer:

Location: Bedford, Massachusetts
Department: Validation
Reports to: Director of Engineering

Job Overview:

We are seeking a highly experienced Validation Lead with over 10-15 years of validation experience in a GMP pharmaceutical and/or medical device aseptic/sterile fill/finish environment. The ideal candidate will have a proven track record of leading validation projects, developing validation strategies, and managing cross-functional teams. This role involves ensuring regulatory compliance and delivering validation projects across equipment, utilities, and processes.

This position is with a global leader in joint health therapies and regenerative medicine, known for developing innovative products aimed at improving patient outcomes. With cutting-edge technology and a commitment to quality, the company focuses on delivering therapies that restore active living to patients worldwide.

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: 10-15+ 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.

Familiarity with relevant software and tools for validation management.