- A new vacancy has arisen for the role of an experienced Process Equipment Engineer at our client’s state-of-the-art pharmaceutical site in Co. Kildare.
- The Process/Equipment engineer will have responsibility for providing engineering and equipment trouble shooting, and qualification support & ensuring that the equipment is running as intended to support the manufacture and timely disposition of product.
- This role focuses on leading and resolving technical issues.
Core Duties and Responsibilities:
- Implementation of CAPAs and process/equipment improvements.
- Generation of product impact assessments.
- Providing routine technical support and trouble-shooting Investigation closeout and maintaining the qualification status of the physical plant and equipment
- The Process/Equipment Engineer is also responsible for Project Management/ execution of assigned projects (short duration), which includes the management of internal company resources (assets financial and personnel), external Engineering and vendors as part of the execution of projects.
- The direct management responsibility includes all support activities and functions necessary to ensure successful completion of project objectives.
- The Process/Equipment Engineer will be responsible for providing technical expertise during audits and to present/defend engineering systems, applicable change controls, investigations and equipment qualification packages to the regulatory agencies if required.
Minimum Qualifications and Experience:
- Minimum qualification of a B.Sc. Degree in Engineering, Science or equivalent with emphasis in Biochemical, Chemical or Mechanical discipline.
- Minimum of 3 year post graduate downstream purification/Vaccines Conjugation experience desirable.
- Experience of process/equipment including Chromatography, Ultrafiltration/Diafiltration, Autoclave, and Parts washer systems would give a distinct advantage.
- Experience working with automated control systems, MCS (Manufacturing Control system), PI (Data acquisition system) and Unicorn
- Demonstrated ability to provide technical solutions for complex problems through equipment/process knowledge.
- Proficient in the use of structured problem-solving tools such as Process Mapping, RCA (Root cause analysis), FMEA’s (Failure Mode effects analysis) etc.
- Excellent communication and interpersonal skills and an ability to work independently.
- Proven record of project delivery.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.