Validation Engineer (Student Placement

☞ PCI Pharma Services

View: 104

Update day: 04-06-2024

Location: Tredegar Wales

Category: Pharmaceutical / Chemical / Biotech

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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

To ensure the qualified state of all cGMP facilities, utilities, manufacturing, packaging and analytical equipment at PCI Tredegar is maintained in accordance with the required risk based, lifecycle approach.
Main Responsibilities Include:
  • To take part in Risk Assessments to determine the validation approach for Facilities, Utilities and Equipment, ensuring those which have a GxP impact are appropriately qualified.
  • To ensure the documentation utilised for Facilities, Utilities and Equipment Qualification has been generated in compliance with Statutory, Regulatory, Client and Company expectations.
  • To work closely with Project Management Teams in Pharmaceutical Development, Technical Affairs, Operations (inclusive of Engineering), Supply Chain and Clients to ensure projects are progressed in a timely manner.
  • To support the execution of Qualification studies, ensuring:
  • All activities are completed in a GxP compliant manner.
  • Standard Operating Procedures (SOPs) and Work Instructions (WIs) associated with the Qualification study are available and adequate for their intended use.
  • Training of Key personnel has been conducted and recorded within the training management system.
  • All equipment used during a Qualification study is appropriately calibrated to a recognisable international / national standard.
  • Any deviation to the acceptance criteria associated with a Qualification study is adequately documented and an action plan agreed as required.
  • All key findings are adequately reported, concluding whether the Qualification study has been successful and whether the system is fit for routine GxP use.
  • To ensure the Site Validation Master Plan is adhered to and maintained in accordance with a risk based, lifecycle approach.
  • To be a Subject Matter Expert in one Validation discipline, and able to represent that expertise at client facing meetings and at audit.
  • To act in a professional manner at all times when liaising with PCI’s client base, to sustain a working environment that promotes the PCI Pharma Services Values and Behaviours.
  • To ensure a Continuous Improvement ethos is upheld, periodically reviewing Standard Operating Procedures (SOPs), Work Instructions (WIs), Templates and Forms with the purpose of standardising and optimising the Qualification approach, whilst still maintaining Regulatory compliance.
Join us and be part of building the bridge between life changing therapies and patients.
Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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Deadline: 19-07-2024

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