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) , 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.
Requirements :
- Degree in Chemical, Mechanical, or Biochemical Engineering.
- Minimum of 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 % (and sitting for %) of a -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.
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