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Validation Project Manager

2 months ago

Durham, North Carolina, United States PSC Biotech Corporation Full time

About the Role

PSC Biotech Corporation is seeking an experienced Validation Project Manager to join our team. As a key member of our engineering team, you will be responsible for developing and implementing validation plans, protocols, and reports for equipment, processes, and systems.

Key Responsibilities

  • Develop and implement validation plans, protocols, and reports for equipment, processes, and systems.
  • Generate and manage project deliverables, preventative maintenance coordination, and risk mitigation.
  • Define and monitor Key Performance Indicators (KPIs) to measure validation effectiveness and report on KPIs to management and stakeholders.
  • Oversee validation projects from initiation to completion.
  • Coordinate with cross-functional teams to align on project schedules, plans, and deliverables.
  • Conduct dry-runs, review, approve, and execute validation documentation.
  • Support overall engineering testing activities by developing, revising, and executing commissioning, validation, and SAT protocols.
  • Implement and review audit trails to ensure data integrity.
  • Provide ongoing support and technical expertise through validation execution and qualification activities.
  • Conduct risk analyses and identify potential risks, recommending areas of improvement.
  • Design, develop, and optimize terminal sterilization cycles for pharmaceutical products.
  • Identify, document, and manage deficiencies and deviations.
  • Perform risk assessments to identify critical process parameters and develop mitigation strategies.
  • Ensure all validation activities comply with FDA, EMA, GAMP 5 and other relevant regulatory bodies.

Requirements

  • Bachelor's degree in a related engineering discipline.
  • 8+ years of validation engineering experience with equipment and computer systems (CSV) in the pharmaceutical/life science industry.
  • Strong knowledge of terminal sterilization processes, cycle development, performance qualification, and process qualification preferred.
  • Proven success in managing, reviewing, authoring, and approving full lifecycle technical documentation.
  • Experienced in generating and executing validation activities on a range of equipment and systems.
  • Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members, and schedule/develop project plans.
  • Experienced in vendor coordination.
  • Excellent technical writing skills.
  • Strong understanding of industry regulations and requirements.
  • Strong attention to detail and commitment to quality and compliance.
  • Strong problem-solving and analytical skills.

What We Offer

  • Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents.
  • Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
  • 401(k) and 401(k) matching.
  • PTO, Sick Time, and Paid Holidays.
  • Education Assistance.
  • Pet Insurance.
  • Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).
  • Financial Perks and Discounts.

Equal Opportunity Employment Statement: PSC Biotech Corporation is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.