- Responsible for the Manufacturing Equipment within the BDS building, including but not limited to Bioreactors, Depth Filtration, Centrifugation, Chromatography, Ultrafiltration/Diafiltration and Process Support systems.
- Engineering expert for specific Manufacturing Upstream and Downstream Areas, have an in-depth knowledge of process operations and equipment to support Manufacturing, Quality, Automation, Validation, and EHS for deviation investigation, change controls, and CAPA’s.
- Technical expert for equipment and accountable for changes to ensure continued compliance of the manufacturing equipment. Generation of requirement for any Equipment/Automation improvements/modifications/projects.
- Ensuring all the systems are in compliance with all Regulatory requirements including Quality, EHS, Global Engineering, design & construction standards, requirements & procedures, as well as all Local Regulatory requirements.
- Supporting internal and external audits as the Engineering SME.
- Responsible for Clean in Place (CIP) and Steam in Place (SIP) changes, support of Validation including periodic assessment.
- Accountable for redlining, reviewing and approving of Automation Functional Specifications and ensuring implementation of software changes to the PAS.
- Review and approval of Drawing updates, and support of out of Specification investigations related to Calibration of critical equipment.
- Perform but not be limited to the following activities: Periodic QRA review of Process equipment, addressing equipment issues identified by IPTs, installation modification of equipment and systems, reducing equipment downtime, support of compliance efforts related to Investigations, CAPA and change management.
- Be an advocate of the Merck Production System and continuous improvement.
Qualifications and Experience:
- The successful candidate will have a BEng in Engineering (Chemical or Mechanical preferred) with 5 years plus experience (or equivalent) with manufacturing equipment support in the Biotechnology manufacturing industry, as well as GMP experience.
- Significant knowledge and expertise of engineering principles related to and expertise with typical biopharmaceutical upstream and downstream processing and support equipment including but not limited to bioreactors, filtration and ultra-filtration, CIP, SIP, centrifugation, chromatography, autoclaves, and parts washers.
- Candidates must be effective in both a team environment and an individual contributor role.
- The job requires high level of technical knowledge and the candidate should have the ability to proactively troubleshoot.
- In-depth knowledge of DeltaV, or other process automation software required; ability to use process historian and analyze data to assist troubleshooting.
- Experience dealing with Regulatory Agencies.
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