Intermediate Pharma Validation Engineer
Found in: Jooble CA O C2 - 2 weeks ago
Resolute Workforce Solutions | Full time
Intermediate Pharma Validation EngineerNorth York, Canada | Posted on 03/13/2024
- Work Experience Intermediate (5 to 8 years)
- City North York
- Country Canada
Resolute Workforce Solutions (Staff augmentation subsidiary of Brevitas Consulting Inc.) is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement, and effective management of change. Our expertise is in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Project Management.
We are looking for a highly motivated and energetic professional to join our team as an Intermediate Pharma Validation Engineer in North York, ON.
This is an on-site position.
Responsibilities:
- Lead all activities associated with the Commissioning & Qualification of Equipment, Utilities, Filling Lines, Water Systems, HVAC, Component Prep Equipment and Formulation.
- Develop Commissioning Master Plan and Validation Master Plan. Coordinate approval of documents as required.
- Create and execute commissioning protocols (FAT or SAT), validation protocols (IQ, OQ, PQ, PV) for process equipment, facility, and utility systems. Develop validation summary reports. Coordinate timely approval of documents as required.
- Manage deviations/non-conformances to ensure timely investigation, root cause analysis and implementation of corrective and preventive actions. Provide technical assistance in support of the resolution of engineering deficiencies and review of design requirements documents (URS, FRS, P&ID, etc) against the company procedures, guidance documents and industry regulations.
- Organize records for each equipment/system including manuals, technical specifications, drawings, reports, etc. as a part of the closure of commissioning and validation activities.
- Bachelor’s degree in the field of Engineering or Science with 7 years’ experience in Commissioning, Qualification and Validation/Quality field in the pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment.
- Areas of expertise: equipment validation, qualification of utilities, Purified/WFI water systems, HVAC, Filling lines, TCUs, component prep equipment, formulation.
- Well-developed communication skills, both verbal and written.
- Life Insurance
- Long Term Disability
- Dental and Healthcare
- Click the “I’m interested” button below, or
- E-mail your resume in MSWord or pdf format to recruitment@resolutewfs.com with the following details in the e-mail's Subject Line: Intermediate Pharma Validation Engineer: FIRST NAME, LAST NAME.
We welcome and encourage applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.
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