Validation Project Manager

4 weeks ago

Indianapolis, Indiana, United States PSC Biotech Full time
About the Role

PSC Biotech is seeking an experienced Validation Project Manager to lead commissioning and qualification projects in the pharmaceutical manufacturing industry. The ideal candidate will have a strong technical background in equipment/system commissioning, qualification, and validation, as well as excellent communication, organization, and project management skills.

Key Responsibilities
  • Drive project success by assessing priorities and project plans, schedule, and budget, and ensure timely and effective resolution of potential risks and issues.
  • Assist in the development of CQV project planning in accordance with project design documentation, equipment specifications, regulations, etc.
  • Develop, review, and execute commissioning, qualification, and validation protocols for required equipment, facilities, utilities, and systems.
  • Conduct risk assessments and develop mitigation strategies for validation projects. Identify, document, and manage deficiencies and deviations.
  • Ensure corrective and preventive action and change control requirements are efficiently met.
  • Maintain accurate and detailed documentation of all validation activities, including protocols, reports, master plans, engineering specifications (URS, DS, FS, etc.), etc.
  • Serve as liaison between vendors and contractors, coordinating required handoffs.
  • Identify opportunities for process improvements and implement best practices in validation activities.
  • Provide ongoing support and technical expertise through validation and qualification activities.
  • Ensure all validation activities comply with FDA, EMA, GAMP 5, and other relevant regulatory bodies.
Requirements
  • Bachelor's degree in a related engineering discipline.
  • 7+ years of commissioning, qualification, and validation engineering experience with a wide range of equipment and systems experience in the pharmaceutical manufacturing industry.
  • Proven success in managing, reviewing, authoring, and approving full lifecycle technical validation documentation.
  • Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members, and schedule/develop project plans.
  • Experienced in vendor coordination/management.
  • Advanced knowledge of industry regulations and standards. Strong knowledge of risk-based validation approach.
  • Experienced in paperless validation (Kneat, ValGenesis, etc.) is a plus.
  • Strong understanding of industry regulations and requirements.
  • Strong attention to detail and commitment to quality and compliance.
  • Excellent problem-solving and analytical skills.
  • Excellent communication and interpersonal skills.
  • Ability to travel as needed for project assignments and client engagements.
What We Offer

PSC Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, PTO, sick time, and paid holidays. We also offer education assistance, pet insurance, and fitness benefits.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking to join a dynamic team, please submit your application.

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