Commissioning Engineer (Biopharma)

Our client is a leading international manufacturer of Cleanroom PODS for the Pharmaceutical & Biopharma sectors. They are seeking an experienced Commissioning Engineer to join their team in Kilkenny, Ireland. Reporting to the Director of Quality in the US, the ideal person will have a strong engineering/construction engineering background with 5+ years commissioning experience. The Commissioning Engineer will be involved in all commissioning activities throughout the POD design, manufacturing and testing process including deviation resolution, project closeout and customer training.

Role/Responsibilities:

Commissioning Documentation Generation - 40%

• Creates test procedures to confirm design and installation of all POD mechanical, electrical, process equipment and POD Automation Systems.

• Verifies that all equipment used in the POD meets industry standards.

• Develops Commissioning Strategy, FAT, and SAT documentation for each POD.

• Creates punch list to track items requiring correction.

Commissioning Execution - 40%

• Travels to job sites across Europe, interacts well with customers (Up to 40% of the time to various suppliers, collaborators and client sites )

• Executes FAT and SAT

• Leads Commissioning activities.

• Follows Good Documentation Practices to ensure that tests performed are clearly and legibly documented.

• Documents any discrepancies/deviations that occur during testing.

• Performs Root Cause Analysis of issues and works with a multidisciplinary team to facilitate the correction of issues.

• Follows customer SOPs in gowning and performing testing in pharmaceutical cleanroom environments.

• Performs on-site training of customer personnel so that each customer can maintain the PODs.

Recordkeeping and Documentation - 10%

• Maintains documentation for work performed

Support of Commissioning Department as Needed - 10%

• Manages Commissioning Equipment

• Generates Commissioning (SOPs) Standard Operating Procedures

• Train other employees


Qualifications/Experience:

• Degree in Construction Science, Engineering, or practical field construction background

•Experience in controls for HVAC systems, including familiarity with current technology, both conventional and direct digital control

•Experience working and knowledge pertaining to Pharmaceutical Cleanrooms

•Knowledge of HVAC systems, covering design, common control strategies, installation, operations and maintenance

•Knowledge of Commissioning according to cGMP standards.

•Skill in authoring test protocols

•Skill in basic computer functions such as word processors, spreadsheets, and internet usage

•Focus and action-oriented.

•Availability to travel up to 40% of the time

• Demonstrated ability to organize many specific activities into a coherent commissioning plan

• Experience working with multi-disciplinary teams

• Ability to make decisions and recommendations

• Ability to demonstrate professionalism with personnel and management

• Collaborative team player

• Ability to gather, organize and analyse information skillfully

• Ability to manage multiple projects concurrently

• Must be able to communicate effectively through oral and written communication

For further details contact Karen Shiel at 087 7452487 or send CV in confidence to [email protected]