Validation Engineer - only on W2

Key Skills: 5+ years of Commissioning experience, Fill-Finish, Pharmaceutical, Vials and/or Syringes

Job Description:

• Our pharmaceutical client is seeking 1-2 commissioning fill/finish experts to support upcoming projects at their facility, which is equipped with fill lines, debuggers, e-beams, chambers, and isolators, configured for both syringes and vials.
• Candidates must have significant experience with vials, while familiarity with syringes is considered a plus.
• Experience in crimping on a filler line is also advantageous.
• The ideal candidate will have a background in decontamination or sterile environments, including smoke studies, temperature controls, and validation processes.
• A minimum of 5 years of experience is required, along with expertise in Factory Acceptance Testing (FAT) and the ability to lead or work independently. Strong documentation skills are essential, with a thorough understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
• Candidates should be well-versed in package commissioning, protocol development, FAT/SAT, and leveraging processes, as well as having a clear understanding of User Requirement Specifications (URS). A solid foundation in fill-finish operations is a must for this role.