Validation Engineer

PUB273188

About this role

We’re hiring a Validation Engineer for our client, a medical isotopes company, to join their team. This is a 1-year contract opportunity

Responsibilities

  • Assist to develop and validate an autoclave sterilization process for a radiopharmaceutical
  • Identify optimal parameters to ensure adequate sterilization
  • Provide technical advice as required to prepare, verify and confirm sterilization calculations
  • Generate development, qualification and revalidation protocols for the sterilization cycle and associated autoclaves
  • Analyze and review raw data, troubleshoot system and/or protocol changes as required during validation activities.
  • Assist in troubleshooting, process optimization and continuous improvements
  • Plan and execute activities to ensure project goals are met
  • Conduct site acceptance tests and commissioning of new equipment and facilities
  • Prepare validation paperwork for and respond to inquiries from Regulatory Authorities
  • Provide support and training to production team
  • Oversight of validation for hot cells, fume hoods, cleaning and manufacturing equipment
  • Oversight of validation and development of revalidation protocols for critical manufacturing equipment

Requirements

Requirements

  • Bachelor’s degree in relevant Science or Engineering
  • Knowledgeable in steam sterilization in the pharmaceutical industry is required
  • 5+ years within the Medical Device or Pharmaceutical fields
  • Experience with sterilization cycle design of a medical device or pharmaceuticals using autoclaves
  • Experience with Current Good Manufacturing Practices, including IQ/OQ/PQ and Validation Development
  • Experience working with electronic systems that are 21 CFR part 11 compliant is an asset
  • Experience working with automated computerized systems (i.e. PLC, SCADA, etc.) is an asset
  • Strong communication, technical writing and presentation skills
  • Ability to deliver results and meet deadlines
  • Excellent organizational and workload prioritizing skills
  • Knowledge of chemical disinfection in pharmaceutical industry is an asset
  • Experience in the radiopharmaceutical industry is an asset
  • Experience in Hot Cell design is an asset.

Benefits

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

Join the Brunel Family

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
Apply now

Any questions remaining?

Your consultant, Maria Camanag is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB273188

Account manager

Maria Camanag
Brunel Canada - Toronto
m.camanag@brunel.net

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