Cleaning Validation Engineer

Woodstock, IL

Posted: 08/30/2019 Job Number: JN -082019-11084

Job Description

Cleaning Validation Engineer

Industry: Pharmaceutical Manufacturing
Salary: $65-$70/hr. depending on experience
Employment: Contract with possible extension
Location: Woodstock, IL
Schedule: M-F, 8am-5pm plus OT including some weekends, must be able to work 70+ hours

Primary Responsibilities:
  • Generate and maintain cleaning validation master plan every year.
  • Proper sampling technique for swab and rinse samples (Demonstration through swab sampling certification program at the site is required after hire)
  • Sponsor change controls for SOPs and Batch Records to update cleaning process for current products
  • Act as Subject Matter Expert for cleaning validation and provide consultation to third party labs for test method development and method validation.
  • Actively provide input and guidance in establishing cleaning process for new products and partner with new product development engineers for process development.
  • Closely work with Operations, Manufacturing Quality, Chemistry, New Product Development and third-party labs to coordinate cleaning validation execution, sample testing and data reporting.
  • Conduct risk assessment of existing and new processes/technology/ equipment and manage the impact of potential failure
  • Familiarity with Blow-Fill-Seal Equipment, Process Tanks, Process Piping, Pumps, Filter Housings etc.
  • Ability to provide consultation and input to Change Controls and Documentation (SOPs, Training Documents, Batch Records, test methods etc.) as it relates to cleaning process.

Must Have Skills:
  • The candidate must be well organized and technically sound in understanding of cleaning validation principles including development of acceptance criteria, worst case product determination from matrix of products.
  • Strong technical writing including protocol generation, deviation investigation and generation as well as report writing
  • Ability to investigate and resolve cleaning validation related Out of Specifications results and deviations
  • Proven hands on experience with pharmaceutical and biologic product Process Equipment
Qualification Requirements:
  • Minimum B.S. degree required, preferably chemical engineering or chemistry.
  • Candidates With minimum 5 years of pharmaceutical or biologics industry experience including a minimum of 2 years of cleaning validation experience will be considered.

Search words: Pharmaceutical, Pharmacy, Quality, QC, QA, Chemistry, Biology, Biomed, Chemistry, Scientist, Science, Validation, Good Distribution Practices, PDA, PFA, cleaning, IP/OQ/PQ

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