Validation Engineer

Found in: Appcast US C2 - 2 weeks ago

Raritan, United States Network Partners Group Full time

Network Partners Group is a life sciences professional services provider whose purpose focuses on the support functions necessary to enable Medical Device, Pharmaceutical and Bio-Tech technologies to be marketed in the global marketplace.


We are a seeking a highly motivated Validation Engineer responsible for independently performing and managing commissioning and qualification activities related to equipment, systems, and processes in a regulated environment.


Key Responsibilities:

  • Responsible for generation of C&Q lifecycle documents – e.g. Project Plan, URS, IQ /OQ / PQ protocols, Traceability Matrix, Summary Reports, 21 CFR Part 11 Assessment and more.
  • Write and execute the Impact Assessments for equipment and facilities, IQ & OQ, and Re-qualification, as well as PQ activities.
  • Assure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WIs, Company policies, and corporate standards.


Education:

  • Minimum of a bachelor’s or equivalent University Degree required, focused degree in Engineering, Science, or related field preferred.


Required:

  • Minimum 4 to 5 years of demonstrated experience with validation of Cell and Gene Therapy and specific to equipment mentioned in the description.
  • Hands on experience with FAT, SAT, IQ, OQ and PQ documentation generation and execution on automated systems.
  • Validation experience in the areas of automation, computer system, utilities and/or facility is desired.
  • In depth knowledge of current GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (e.g., ISO, EN, ICH, FDA, FAGG/FAMHP, ISPE)
  • Service mentality and ability to proactively collaborate with teams and partners, working hands-on on all aspects of C&Q tasks, while identifying areas of improvement

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