Senior Bioprocess Commissioning Specialist
1 month ago
Overview
MMS Consulting, a renowned engineering and consulting firm specializing in the pharmaceutical and biotechnology industries, is seeking an experienced Senior Bioprocess Commissioning Specialist to join our team. As a key member of our commissioning and qualification group, you will play a vital role in ensuring the successful completion of projects.
Salary: $120,000 - $150,000 per annum, based on qualifications and experience
About Us
We offer a unique opportunity to work with a talented team of engineers and specialists involved in project management, commissioning, and qualification. Our services include Engineering, Project Management, and other Consulting services. MMRs expertise includes Process Automation, Facilities engineering, Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).
Job Description
We are seeking a skilled Senior Bioprocess Commissioning Specialist with extensive experience in commissioning, qualification, or validation of various systems within the pharmaceutical/biotech industry. The ideal candidate should possess leadership skills to lead/mentor intermediate/junior engineers.
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 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.
Required Skills and Qualifications:
- 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 a 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.
Benefits
- Competitive salary ranging from $120,000 to $150,000 per annum
- Opportunities for professional growth and development
- A dynamic and supportive work environment
Other Requirements:
- 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.
- Strong multi-tasking skills
Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally.
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