Jacobs Site Commissioning Lead in Stockport, United Kingdom
Site Commissioning Lead
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.
Qualifications & Experience:
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’S, regulatory requirements, equipment commissioning and qualification
Key Competencies: (Education, Training, Skills, Experience)
Commissioning Lead: A degree in chemical, mechanical, or electrical engineering or equivalent
Commissioning Lead: A degree in Chemistry, Microbiology, Physics, Biochemistry or equivalent.
A certificate/diploma in similar areas with appropriate industrial experience
Experience of Commissioning Qualification in the biopharmaceutical industry. (5-10 yrs)
Additional Competencies: (Education, Training, Skills, Experience
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
Primary Location United Kingdom-United Kingdom Countrywide-Stockport
Req ID: LIF0000AR