Pharmaceutical Manufacturing Engineer
We are seeking a highly skilled Pharmaceutical Manufacturing Engineer to join our expanding team in Cork. As a key member of our projects team, you will be responsible for supporting multiple projects with leading Pharmaceutical and Biotech companies.
Job Description
The ideal candidate will have experience in automation change review and approval, with a strong background in Emerson Delta and other DCS systems. They will also be responsible for developing and completing continuous improvements as part of the validation team, coordinating changes to ensure timely delivery, and generating installation and operation qualification protocols.
Responsibilities
* Automation Change (IRIS) Review and Approval
* Experience with Emerson Delta and other DCS systems
* Develop and complete continuous improvements as part of the validation team
* Coordination of changes to ensure timely delivery
* CSV deliverables including 21CFR11 assessments, Annex 11 assessments, Business Criticality assessments, and GAMP assessments
* Review and approval of automation designs
* Installation and Operation Qualification (IOQ) protocol generation, execution, and reporting for DeltaV PAS PLCs and Honeywell QBAS/NQBAS MES
* Test specification pre-approval review and post-approval prior to progression to IOQ
* Change control impact assessments
* Maintenance review and approval of site quality documentation
Required Skills and Qualifications
* Bachelor's degree in Engineering, Computer Science, or a related technical field
* Minimum 5 years' experience working in a pharmaceutical API manufacturing operation
* Experience with labware and LIMS is essential
* Excellent communication and interpersonal skills
* iRCAS communication skills
* Availability to work minimum 4 days per week onsite
Benefits
We offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive salary package.
About Us
We are a world leader in delivering digital transformation solutions to Life Sciences. Our teams have the expertise to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT, and IoT applications, infrastructures, and services.