Katalyst CRO

Process & Validation Engineer

10 months ago

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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.