Manufacturing Shift Engineer

Job Description

Purpose:

 

This role will be part of our operations technical support team, with day to day responsibilities in the Manufacturing team in our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland.

 

The Shift Engineer will work across the site teams to identify and resolve issues in order to allow the site to deliver on our commitment to support Quality, EHS, Technical problem solving and Continuous improvement.

 

The Shift Engineer will be responsible for the use of process engineering systems and approaches during processing shifts for monitoring equipment and process performance, being the main point of contact for real-time process monitoring and troubleshooting, ensuring equipment and process is performing optimally and safely to support production activities, acting as subject matter expert (SME) support to deviation investigations, and using risk management techniques to prioritize activities and initiatives. Ongoing optimization of process equipment and development of future breakthrough business solutions will be key focus areas. The role will involve being a key point of contact and liaison between Manufacturing Operations and Manufacturing Technical Support, working as part of a team of scientists, engineers and support specialists who will be responsible for supporting routine batch activities and transform the business initiatives. The shift engineer will be imbedded on the manufacturing floor with production personnel during shift operations in order to provide real time response to issues and play a key role in the coaching and development of the Manufacturing team. 

Responsibilities:

• Work with the Integrated Process Team (IPT) to ensure the effective and efficient on-time delivery of batch production within the IPT area.

• Support operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Production Plan,, technical support, compliance and team training.

• Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.

• Support the execution of engineering, clinical and commercial manufacturing processes according to established work instructions and Standard Operating Procedures.

• Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan.

• Ensure supply of high-quality product through equipment availability.

• Provide technical, process and engineering expertise within a wide range of projects within the IPT.

• Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.

• Resolve issues and identify risks and escalate in a timely fashion.

• Act as a key point of contact for the introduction of new process equipment into the facility, and provide technical support for the operations based manufacturing personnel as equipment is brought on line.

• Have an in depth understanding of specific EBRs in the facility, making technical changes are required to meet the demands of the business or in response to any requirements for process changes that may occur.

• Pull together cross functional teams to deliver on deviations, improvements and equipment changes that will move the production processes forward in the facility.

• Support/Drive future updates to the batch recipe on the PAS (process automation system), the BOM (bill of materials) and the EBR (electronic batch record) for specific process steps.

• Responsible for the generation and approval of GMP documentation to support compliance and regulatory expectations for manufacturing operations: change control management and implementation, closure of significant technical investigations, process improvement opportunity identification through implementation, regulatory license section authoring through response-to questions, health authority inspection SME support, and more.

• Adhere to Right First-Time principles.

• Maximize team member performance through continuous process improvement initiatives.

 

Education & Experience:

 

• Minimum Level 8 qualification in Science, Engineering or related discipline or equivalent industrial experience.

• 3-5 years experience in a regulated pharmaceutical manufacturing environment, preferably in technical or operations roles.

• Demonstrated knowledge of continuous improvement methodologies & in-depth understanding of site level products & related processes.

• Demonstrated collaboration, negotiation & conflict resolution skills.

• Excellent communication skills (written and oral).

• Demonstrated understanding of continuous / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).

• Exceptional analytical, problem solving & root-cause analysis skills.

• Ability to multi-task and handle tasks with competing priorities effectively.

• Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.

• Experience with working in a multinational organisation

 

Other Job Requirements;

This role is a shift based role and location of work is onsite.

Required Skills:

cGMP Guidelines, Electronic Batch Records, Manufacturing, Manufacturing Engineering, Process Engineering, Process Optimization, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Teamwork, Troubleshooting

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/4/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.