- Job Type:
Site Commissioning Lead Engineer
• To provide Commissioning expertise to project teams on sites
• To provide Commissioning expertise on our client's sites when such requests arise (i.e. secondment type work)
Main Duties and Responsibilities:
• Functional testing of equipment in an API manufacturing plant. Systems include dissolution, crystallization and solids isolation (pressure filtration), drying equipment, temperature-controlled units, nitrogen insertion 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 i.e. 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
At First Recruitment we understand just how important it is to secure the right people. That's why our consultants always take the time to understand requirements in detail and offer sound advice to both clients and candidates.
This is a superb opportunity for anyone looking to work for a reputable organisation.