Process & Validation Engineer

Responsibilities:

• Write and execute commissioning, qualification, & validation protocols for facilities, utilities, and process equipment.
• Oversee and review design and construction work related to cGMP manufacturing facility.
• Review submittals, IOM, control sequences, and start up procedures.
• Perform Walk Downs of As-Built P&IDs and Redlining P&IDs as required.
• Document and manage all punch lists and deviations.
• Write and review deviations, CAPAs, Change Controls, etc.
• Perform basic revisions as needed to accurately reflect current procedures.
• Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE) i.e., scrubs, gowning coverall, masks, gloves, etc.
• Work in both an office and a manufacturing lab setting.
• Work in a lab setting with various chemical/biochemical exposures, including latex and bleach.
• Work in a cleanroom with biohazards, human blood components, and chemicals.
• Support project management initiatives to ensure efficient and timely progress.
• Additional relevant duties as needed.

Qualifications:

• Degree in Chemical, Mechanical, or Biochemical Engineering.
• Minimum of 3 years of experience writing and executing CQV in the Pharmaceutical Industry.
• Able to read and understand system drawings, diagrams, and specifications.
• Experience collaborating with other design disciplines such as automation, facility design, and mechanical design groups.
• Experience working closely with CQV and operations teams is essential.
• Meticulous attention to detail and commitment to follow-through.
• Experience in working in cleanrooms and familiar with gowning requirements.
• Capable of standing and/or walking for 90% (and sitting for 10%) of a 10-hour day, which may involve climbing ladders or steps.
• Must have near vision acuity for viewing samples at close range.
• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, and analytical skills.
• Must be able to manage multiple priorities simultaneously and have the ability to meet deadlines.