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Cleaning Validation Engineer (Pharma/Biotech)

Company:
PSC Biotech
Location:
Limerick, Country: Ireland
Job Type:
full-time, contract, permanent
Job Description

About PSC Biotech

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Responsibilities:

  • Taking Cleaning samples alongside Upstream/Downstream processing.
  • Working closely with manufacturing to ensure the CIP are initiated and samples are taken.
  • Shows focus & a consistence approach to the role and tasks.
  • Generating and Executing Validation Protocols.
  • Actively look for Continuous improvements
  • An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment works and load configuration for small parts loads
  • Generate/review/Approval of cleaning validation and SIP protocols,
  • Generation of Summary Reports and strong quality background essential
  • Maintain and update Cleaning Validation Plan
  • Ability to work on own initiative
  • Schedule of cleaning/ SIP activities with Manufacturing
  • Liaise with numerous departments
  • Ensure Training is maintained and current.
  • Follow all EHS/Safety SOP/Policies
  • Shift may be required.

Requirements:

  • Experienced in QA Validation activities –
  • Execution of cleaning validation protocols.
  • Experience on writing and approving Deviations/ GMP documents
  • Technical writing experience in writing site reports.
  • Experience in Validation specifically CIP/SIP validation or QA background
  • Experience in assessment of cleaning issues during study runs,
  • Experience in cleaning validation/ SIP results reporting review beneficial
  • Experienced Technical writer
  • Experience in Deviation and investigation writing and data review
  • Experience in continuing validation and generation of assessments for continuing
  • Excellent people skills
  • Experience in aseptic technique
  • Experience in Gowning for IOS7/ISO8

Job Types: Full-time, Contract, Permanent

Experience:

  • cleaning Validation : 2 years (Required)
  • Pharmaceutical / Biotech Industry: 1 year (Required)

Education:

  • Bachelor's (Preferred)
Job Settings
Number of jobs: 1 hires
Information about the advertiser
Company: PSC Biotech
Company size: 1-49
Contact: NA