Leads commissioning, qualification, and validation activities for GMP-regulated systems, facilities, and equipment. Authors and executes DQ, FAT, SAT, IQ, OQ, PQ, and PV documentation; develops SOPs, validation reports, and quality policies; supports temperature mapping and autoclave qualification; coordinates project timelines and stakeholders; and ensures compliance with cGMP, regulatory standards, and quality systems.
POSITION SUMMARY:
The C&Q Engineer is responsible for ensuring systems, facilities, and equipment
meet design requirements to be put in place for a facility.
Key Responsibilities
- Plan, coordinate, and execute commissioning, qualification, and validation activities for GMP systems and equipment.
- Develop and review qualification protocols, test documentation, and validation reports.
- Writes and revise GMP and GDP documents and technical specifications.
- Support FAT, SAT, commissioning, and qualification activities throughout the project lifecycle.
- Support development of SOPs and review final reports.
- Collaborate with Engineering, Quality, Manufacturing, and Project teams to ensure successful project delivery.
- Mentoring and providing consultation to the client and local team.
- Ensure compliance with cGMP requirements, regulatory standards, and company quality systems.
- Responsible for managing project activities and timelines.
- Provided status reports of projects to the PSC Project Manager.
Requirements
Requirements:
- Bachelor Degree in Engineering, Science, or a related discipline.
- 5+ years’ experience within pharmaceutical, biotechnology, medical device, or other GMP-regulated environments.
- Experience applying a risk-based CQV (Commissioning, Qualification & Validation) approach.
- Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
- Proficient in developing SOPS, final reports and validation & quality policies.
- Understanding, developing, executing and maintaining CQV procedures and policies.
- Experience performing temperature mapping of Controlled Temperature Chambers (CTCs) using systems such as Kaye Validator and/or Testo.
- Experience performing temperature mapping and qualification of benchtop autoclaves.
- Experience with digital validation platforms, preferably Kneat.
Similar Jobs
Digital Media • Information Technology • News + Entertainment
Manage and optimize relationships with premium publisher partners using FreeWheel products. Troubleshoot programmatic and IO-based deal delivery, pacing, setup, and performance issues; provide supply performance insights; identify growth opportunities; and coordinate with product, operations, and support teams to resolve issues. Serve as a programmatic subject matter expert while delivering high-touch client service and supporting strategic account plans.
Top Skills:
Ad Serving TechnologiesFreewheelExcelProgrammatic AdvertisingSupply-Side Platforms (Ssps)
Cloud • Fintech • Information Technology • Machine Learning • Software
Lead web strategy to align marketing and product goals, translating design into technical requirements, prioritizing web backlog, optimizing user journeys via analytics/CRO, evolving CMS and component libraries, conducting design QA, and coordinating cross-functional delivery with engineering and product.
Top Skills:
Analytics PlatformsCmsConversion Rate Optimisation TestingCSSFigmaHTMLJIRA
Digital Media • Information Technology • News + Entertainment
Manage and optimize publisher partnerships for FreeWheels ad platform. Act as a trusted advisor, troubleshoot programmatic and IO delivery issues, analyze supply performance, coordinate cross-functional resolutions, and drive account growth through data-driven recommendations and stakeholder relationships. Provide high-touch service and support global coordination.
Top Skills:
Ad Serving TechnologiesFreewheelExcelProgrammatic AdvertisingSsps
What you need to know about the Melbourne Tech Scene
Home to 650 biotech companies, 10 major research institutes and nine universities, Melbourne is among one of the top cities for biotech. In fact, some of the greatest medical advancements were conceptualized and developed here, including Symex Lab's "lab-on-a-chip" solution that monitors hormones to predict ovulation for conception, and Denteric's vaccine for periodontal gum disease. Yet, the thousands of people working in the city's healthtech sector are just getting started, to say nothing of the tech advancements across all other sectors.
