The Research and Development Utilities Specialist supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. The R&D Utilities Specialist Technologist will ensure Research and Development facility and utilities (HVAC, Compressed air, purified water, etc.,) are installed, qualified, validated, calibrated and maintained in adequate working conditions and in accordance with cGMPs.
This position performs activities assigned by R&D Equipment and Utilities Supervisor, R&D management/upper management to meet the company's goals within the specified timelines. This position also requires documenting, reviewing, analyzing and interpreting data in a timely manner while complying with departmental SOP's and guidelines set out by the regulatory agencies, ISPE (International Society for Pharmaceutical Engineering) and ICH (International Conference on Harmonization). This will be achieved by working very closely with the Formulation Development, Analytical Development and R&D QA teams.
Key job responsibilities and duties:
- Perform Purified Water Qualification, HVAC and Compressed Air Commissioning and Qualification.
- Perform in-house Preventative Maintenance (PM), Calibration and Qualification of new and existing utilities, facility, and processes with a focus on cGMP compliance.
- Review PM, Calibration, and Qualification documentation of new and existing utilities, facility, and processes with a focus on cGMP compliance for third party.
- Prepare and execute equipment qualification documents including but not limited to: IQ, OQ, and PQ Protocols and IQ, OQ and PQ executed summary Reports.
- Coordinate with external vendors and contractors as required and arrange for services such as PM/Calibration, purchase of spare parts, new instruments/equipment, instrument calibration, and equipment qualification.
- Writes or assists in writing deviations, change controls, repairs reports and Out of Specification Calibration investigation reports pertaining to utilities, facility, and processes in compliance with cGMP’s.
- Assist in Writing and performing GxP Computerized System Validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRA, FS, DS, Trace Matrix, Protocols, Test scripts and Reports.
- Support the maintenance of Analytical and Formulation Development equipment and related software in accordance with GMPs, and current regulatory expectations for data governance and data integrity.
- Participate in periodic review of Computerized Systems.
- Assist in PM/Calibration/qualification for AD Analytical Equipment and FD instruments, if required.
- Other duties as assigned.
Education and experience requirements:
- Canadian equivalent to Master of Science or Bachelor of Science degree, preferably in Pharmacy, Chemistry, Pharmaceutical Chemistry or Engineering.
- More than three years of relevant Canadian hands-on pharmaceutical experience in water qualification, HVAC and Compressed Air qualification.
- Strong knowledge of Health Canada, FDA regulations, ISO, ISPE, ICH guidelines and GMP regarding facilities.
- Experience with Computer Software Validation and Good Automated Manufacturing Practice is highly desired.
- Demonstrated ability to work independently or as a part of a team, and to coach less experienced colleagues.
- Highly motivated and have the skills to handle multiple projects and prioritize the work.
- Excellent communication skills (oral and written) and interpersonal skills are required.
Job Type: Full-time
Pay: Up to $68,000.00 per year
Benefits:
- Casual dress
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Tuition reimbursement
- Vision care
Education:
- Bachelor's Degree (preferred)
Experience:
- water qualification, HVAC and Compressed Air qualification: 3 years (preferred)
Work Location: In person