• 
  Develop and execute
  commissioning, qualification, and validation protocols for API manufacturing equipment and systems.
• 
  Prepare and
  maintain comprehensive documentation, including
  validation protocols, plans, reports, and standard
  operating procedures.
• 
  Identify and assess
  risks associated with CQV activities and develop effective
  mitigation strategies.
• 
  Troubleshoot and
  resolve issues related to API equipment and process
  performance.
• 
  Collaborative with
  cross-functional teams to ensure alignment on CQV activities
  and project timelines.
• 
  Ensure compliance
  with regulatory requirements (FDA, EMA, etc.) and industry
  standards (GMP, GAMP, etc.).
• 
  Additional
  responsibilities as required to drive successful validation
  project deliverables.

Requirements

• 
  Bachelor’s degree
  in Engineering, Life Sciences, or a related field.
• 
  Varying years of
  equipment commissioning, qualification, and validation
  engineering experience supporting API manufacturing or drug substance facilities within the pharmaceutical and/or biotech industries.
• 
  Strong knowledge of
  regulatory requirements and industry standards.
• 
  Experience with
  validation lifecycle management and risk-based approaches.
• 
  Excellent
  analytical and technical problem solving skills.
• 
  Strong technical
  writing skills and understanding of full lifecycle
  documentation (protocols, reports, procedures, risk
  assessments, specifications and requirements, etc.)
• 
  Effective
  communication and interpersonal skills.
• 
  Proactive with
  strong organization, time management, and project
  management abilities.
• 
  Excellent attention
  to detail with commitment to quality and compliance.
• 
  Must be authorized to
  work in the US.
• 
  No C2C at this time.

Benefits

• 
  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
• 
  Discounted rate at
  Anytime Fitness
• 
  Financial Perks and
  Discounts