- An exciting new vacancy has arisen for an Automation Engineer at our client’s biopharmaceutical facility in Co. Waterford.
- The Automation Engineer will be responsible for the design, selection, installation and qualification of automation process equipment in the company’s future Drug Substance facility.
- The Automation Engineer will also be responsible for budget and schedule adherence for the automated systems, and coordination with a cross functional team to ensure successful project delivery.
Core Duties and Responsibilities:
- Prioritises safety and is diligent in the use of all appropriate safety tools and permits
- Works with manufacturing, technical operations, engineering and quality colleagues to ensure successful delivery of automated process equipment
- Manages specialist consultants and system integrators in the production of project deliverables
- Supports the delivery phase of design, construction and qualification of the drug substance facility
- Ensures adherence to program schedule and associated budgets with regular reporting of progress
- Establishes and implements project management process to support successful project delivery and visibility
- Supports validation activity in process manufacturing areas
Minimum Qualifications and Experience:
- Bachelor’s Degree in Engineering, Pharmaceutical Sciences, or related Science
- Further qualification (Masters) in related discipline
- Specific knowledge of bio-pharmaceutical and sterile pharmaceutical manufacturing processes and technologies, ideally, upstream (cell culture and harvest) / downstream (purification and bulk filling) unit operations, Clean Utilities (Clean Steam, WFI, Process Gases) and CIP/SIP operations
- Strong analytical skills, documentation skills and research skills
- Very strong problem-solving skills, ideally using formal tools e.g. FMEA
- Strong understanding of pharmaceutical industry regulatory requirements
- At least 10 years’ relevant experience in a pharmaceutical manufacturing environment, with at least 5 years’ experience in a comparable automation engineering role
- Must have experience working in a bio-pharmaceutical manufacturing environment
- Experience with some or all of the following processes:
- DCS and PLC/SCADA systems
- Equipment Integration
- Batch Systems (S88) and MES (S95)
- Data Historians
- Data Integrity, 21 CFR Part 11 / EU Annex 11
- Computer System Validation
- Proficient in Microsoft Office
- Professional, proactive demeanor
- Strong interpersonal skills
- Excellent written and verbal communication skills
To Apply: Quote – PE22096
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland.
+353 21 2066178
Please note, we do not require agency assistance with this role.