Biopharmaceutical System Integration Specialist
3 weeks ago
We are seeking an experienced Biopharmaceutical System Integration Specialist to join our team at MMR Consulting. This is a unique opportunity to work with a talented group of engineers and specialists in project management, commissioning, and qualification of equipment, systems, and facilities.
Job DescriptionThe successful candidate will work on the commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries.
Key Responsibilities:- Provide technical guidance into the commissioning, qualification, and start-up of various equipment and facilities.
- Lead the development of key qualification deliverables during the project lifecycle to ensure the project is well defined, and the action plan to test the system is applicable and relevant.
- Lead qualification processes throughout the project lifecycle, such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ, and PQ, as appropriate, to ensure timely completion and to ensure all quality and engineering specifications are met.
- Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
The ideal candidate should possess leadership skills to lead/mentor intermediate/junior engineers and have experience with C&Q parts washer and autoclave. Experience with C&Q of other process equipment, utilities, facilities is an asset. Thermal Validation experience is also an asset.
Requirements:- Excellent written and spoken English is required, including the preparation of technical documents in English.
- Years of experience: 8+ years for years of experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry, where minimum 6 years should include direct C&Q experience with upstream or downstream bioprocess equipment/systems.
- Knowledge of requirements for cGMP operations, including SOPs, Change Controls, Validation.
- Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset.
- Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, or a related discipline.
- Ability to handle multiple projects and work in a fast-paced environment.
Salary Range: $120,000 - $180,000 per year, depending on experience.
MRR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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