My client is a Biopharmaceutical company based in the North West. Due to an expansion project they are looking for a Commissioning Engineer with API experiance Primary Function:
Main Duties and Responsibilities:
- To provide Commissioning expertise to project teams on sites
- To provide Commissioning expertise on our client sites when such requests arise (i.e. secondment type work)
Qualifications and Comments
- Functional testing of equipment in an API manufacturing plant. Systems include dissolution, crystallization and solids isolation (pressure filtration), drying equipment, temperature-controlled units, nitrogen inertion and waste systems.
- Preparation/review of commissioning documents, including water and solvent batch testing documents
- Interfacing with representatives on project team, Construction, Engineering, package vendors, Automation, Quality and End Users.
Key Competencies: (Education, Training, Skills, Experience)
- Educational Professional Qualifications Required
- Degree in Science or Engineering (or equivalent experience)
- Relevant experience of Biopharma/pharma company in commissioning, engineering or operations
- Hands- on experience of the start-up and on-going operation of pharma process and utility systems
- Hands-on experience of process control system eg. DeltaV or equivalent
- Proven hands-on experience of the operation of API process equipment ie dissolution, crystallization and solids isolation (pressure filtration) equipment, supporting utilities.
- Knowledge of GMP regulatory requirements, equipment commissioning and qualification
- Commissioning Lead: A degree in chemical, mechanical, or electrical engineering or equivalent
- Commissioning Lead: A degree in Chemistry, Microbiology, Physics, Biochemistry or equivalent.
Additional Competencies: (Education, Training, Skills, Experience)
- A certificate/diploma in similar areas with appropriate industrial experience
- Experience of Commissioning Qualification in the biopharmaceutical industry. (5-10 yrs)
In order of priority:
- Experience of Commissioning in similar engineering company and project environment.
- Experience of Commissioning in the general pharmaceutical industry. (3-5 yrs)
- Experience with Regulatory and industry standards for GMP and GEP
- Experience using the ISPE baseline guides
- Good team player
- Good oral and written communication skills