Engineering Compliance Specialist

Job Description

A fantastic opportunity has arisen for an Engineering Compliance Specialist, in our newest state-of-the-art, fully integrated vaccine facility, in Dundalk.

You will play a critical role in ensuring that all engineering activities comply with internal standards, industry regulations, and global pharmaceutical quality requirements. This role involves auditing, monitoring, and supporting engineering processes to maintain compliance with GMP, safety, and environmental regulations. The specialist will work closely with the rest of the Engineering team, Quality, Operations and above site regulatory teams to proactively identify compliance risks and implement corrective actions.

Bring energy, knowledge, innovation to carry out the following:

• Investigations & CAPA: Lead deviation and out-of-tolerance investigations end-to-end - failure analysis, true root cause identification, and effective CAPA implementation. Author clear, defensible investigation reports requiring minimal rework.
• Audit readiness & inspection support: Own the Engineering Department's audit readiness programme and act as engineering liaison during internal, external and regulatory inspections (HPRA, FDA, EMA), ensuring timely, accurate and compliant responses.
• Metrics & trending: Prepare and analyse quality metrics and trend reports; use the data to drive continuous improvement in compliance and operational performance.
• Procedures, change control & documentation: Maintain and periodically review engineering SOPs, protocols and compliance documentation; support change controls to ensure alignment with regulatory requirements and internal standards.
• Risk assessment: Participate in Quality Risk Assessments and risk assessments for engineering changes, maintenance activities and capital projects.
• Validation & qualification support: Support validation/qualification of engineering systems and equipment, ensuring regulatory adherence and documentation quality.
• Training & coaching: Coach engineering personnel on GMP, compliance requirements and best practices.
• Cross-functional delivery: Work closely with Facilities, Projects, Quality, EHS and Technical Engineering teams. Confidently engage and, where necessary, challenge stakeholders — including escalating compliance risks to senior leadership.

What skills you will need:

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related discipline).
• Proven experience in Engineering compliance, Quality Assurance, or validation within pharmaceutical manufacturing or a regulated industry.
• Strong knowledge of GMP, FDA, EMA regulations, and pharmaceutical engineering standards.
• Experience with engineering validation, qualification, and documentation practices.
• Excellent attention to detail and strong analytical skills.
• Effective communication and interpersonal skills to work collaboratively across functions.
• Ability to manage multiple tasks and prioritize in a fast-paced environment.
• Proficiency with compliance management systems and Microsoft Office applications.
• Knowledge of risk management and CAPA processes is an advantage.

Our Companies in Ireland is one of the country’s leading healthcare companies, having first established here 50 years ago. The company has a dynamic and inclusive team of over 4,000 employees currently working across eight locations in Ballydine, Co. Tipperary, Brinny, Co. Cork, Dunboyne, Co. Meath, Dundalk, Co. Louth, Carlow and Dublin, and, in addition, operate substantial Human Health and Animal Health businesses. We work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network.  

As a cutting-edge, state-of-the-art vaccines facility spanning over 15,500 square metres across three stories, our Dundalk site will focus on qualification, continued product development and expanding its capabilities within our network. Featuring drug substance manufacturing, drug product manufacturing and quality control labs that will support the global supply of vaccine products - strengthening our ability to make an impact on people and patients worldwide by adding new capabilities to our already industry-leading network. 

Required Skills:

CAPA Processes, Compliance Risk Management, Computerized Maintenance Management Systems (CMMS), GMP Compliance, Pharmaceutical Process Engineering, Quality Risk Assessment, Regulatory Compliance, Vendor Management

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

Secondary posting:

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing inclusive, talented, and committed people together.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/29/2026

*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.