Cpl in partnership with our client Pfizer are currently recruiting for Verification Engineer(s) based in their Grange Castle Facility. The role is to support the validation of the ReFacto equipment adopting the Verification approach. The role will involve commissioning and verification / qualification of systems:
• Ensuring that equipment works to its specification and process requirements.
• Creating and carrying out test procedures.
• Design & testing of Automation (Delta V) code to meet process requirements.
• Writing reports and documentation.
• Critiquing of verification results to ensure systems released are robust and fit for use.
The role may support execution of the Engineering/Demonstration batch phase following completion of verification activities.
• Documentation preparation/review: Commissioning and Verification Test Plans and Scripts.
• Field execution of Commissioning and Verification Test Plans.
• Co-ordination/Review of construction & vendor packages.
• Coordinating/supervising activities of vendor representatives and subcontractors.
• Working with Automation Engineering in the design of the Delta V code to ensure it meets all process and equipment requirements.
• Providing technical support, investigating problems and diagnosing and repairing faults, troubleshooting.
• Ensuring safe execution of all commissioning activities through the application of all relevant safety guidelines and procedures.
• Scheduling and coordinating work to tight deadlines.
• Providing progress updates for systems/equipment and maintaining project progress to agreed timelines.
• Identifying, escalating and resolving issues in a timely manner as required.
• Training maintenance and operative staff where appropriate.
• Support Water and Engineering/Demo batches.
• Assist with inspection readiness activities including preparation of playbooks.
• At least 5 years of experience working in the commissioning and verification/ qualification of equipment.
• Familiarity with the operation of cell culture and purification technology and relevant technical expertise (e.g. Delta V, Bioreactors, Vessels, Pumps, Agitators, Chromatography).
• Excellent interpersonal and oral & written communication skills.
• Strong evidence of problem solving skills.
• The ability to work well under pressure.
• Team-working skills.
• Knowledge and experience with a plant start-up.
• Good IT and analytical skills.
• Knowledge of recent regulations/guidelines (ICH, Eudralex, ASTM, FDA, ISPE) and modern commissioning and qualification practices. Experience of ASTM E2500 an advantage
• A minimum of a B.Sc., B.E. or M.Sc./M.Eng. Degree in Biosciences, Chemical Engineering
or equivalent; equivalent defined as a Biotechnology or Industrial Chemistry Degree with
a large element of engineering fundamentals as applied to biotechnology in the curricular.
• Educational qualification can be supplemented with relevant industrial experience in this field.
Other Information - Internal
This role is open to European Passport Holders, or Full Stamp4 Visa Holders Only.
Interested in the above role? - Why not pick the phone and we can discuss in confidence.
Eamonn: 01 614 6069 - If you'd like to send your CV on for consideration: email@example.com