Process & Validation Engineer

Katalyst HealthCares and Life Sciences

• $75K — $95K *
King Of Prussia, PA 19406In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Degree in Chemical, Mechanical, or Biochemical Engineering.
  • Minimum 3 years experience in CQV within the Pharmaceutical Industry.
  • Proficient in reading system drawings and specifications.
  • Collaborative experience with automation and facility design teams.
  • Strong attention to detail and commitment to task completion.
  • Previous cleanroom work experience with gowning protocols established.
  • Ability to manage multiple priorities and meet deadlines.

Responsibilities

  • Write and execute protocols for commissioning, qualification, and validation of facilities.
  • Oversee cGMP manufacturing facility design and construction work.
  • Review technical documents and compliance submittals.
  • Perform walk-downs of as-built P&IDs and redline as needed.
  • Document and manage punch lists and deviations effectively.
  • Draft and review deviations, CAPAs, and change controls.
  • Support project management for efficiency and timely deliverables.

Benefits

  • Opportunities for professional growth and development.
  • Comprehensive health benefits and wellness programs.
  • Support for continuing education and certifications.
  • Access to cutting-edge technology and processes in the lab.
  • Work in a collaborative environment with interdisciplinary teams.
Full Job Description
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.
* Ladders Estimates

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