3 Days Left Spclst, Engineering

This job is with MSD, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Job Description
Job Description
Our Engineering team at our Dundalk facility are looking to hire an exciting role for an Engineering Compliance specialist . This person will play a critical role in ensuring that all engineering activities at Our Company Dundalk 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:
Direct and lead investigations of deviations, out-of-tolerance conditions, and unexpected results; conduct failure analysis, determine root causes, and implement effective corrective and preventive actions (CAPA) to prevent recurrence.
Prepare and analyze quality-related metrics and trend reports to identify opportunities for improved operational efficiency and compliance within the Engineering Department.
Support the update, periodic review, and implementation of engineering procedures and change controls to ensure alignment with regulatory requirements and internal standards.
Participate actively in Quality Risk Assessments (QRA) for the Engineering Department to identify, evaluate, and mitigate potential compliance and operational risks.
Lead the Engineering Department's audit readiness program, ensuring preparedness for internal, external, and regulatory inspections.
Coordinate Engineering Department support during regulatory audits and inspections, acting as a key liaison to ensure timely, accurate, and compliant responses.
Accountable for leading thorough investigation analyses, identifying true root causes, recognizing compliance gaps, and driving closure actions to ensure sustained compliance and operational excellence.
Collaborate closely with Integrated Facility Management (IFM) colleagues and cross-functional teams including Integrated Project Teams (IPT), Quality, Environmental Health & Safety (EHS), and Technical Engineering to ensure best practices and compliance are maintained.
Support validation and qualification activities for engineering systems and equipment, ensuring adherence to regulatory standards and documentation requirements.
Maintain and control engineering compliance documentation, including Standard Operating Procedures (SOPs), protocols, and audit reports, ensuring accuracy and accessibility.
Provide training and coaching to engineering personnel on compliance requirements, GMP, and best practices to foster continuous learning and adherence.
Assist in risk assessments related to engineering changes, maintenance, and capital projects to minimize operational risks and ensure compliance.
Utilize compliance management systems and tools to track, report, and monitor compliance status and CAPA progress effectively.
Drive continuous improvement initiatives within the Engineering Department focused on compliance, quality, and operational excellence.
Support sustainability and environmental compliance initiatives related to engineering activities.
What skills you will need:
In order to excel in this role, you will more than likely have:
Bachelor's degree in engineering (Mechanical, Electrical, Chemical, or related discipline) or equivalent experience.
Experience (typically 3-5 years) 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.
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 diverse, 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.
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable Shift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Analytical Instrumentation, Automation Systems, Bioprocessing, cGMP Compliance, Change Control Processes, Computerized Maintenance Management Systems (CMMS), Corrective Action Management, Data Analysis, Electrical Systems, Environmental Regulations, Environment Health and Safety, Failure Analysis, GMP Compliance, Good Manufacturing Practices (GMP), Maintenance Supervision, Mechanical Systems, Operational Efficiency, Pharmaceutical Process Engineering, Process Control, Regulatory Compliance, Regulatory Inspections, Risk Assessments, Standard Operating Procedure (SOP)  Preferred Skills:
Job Posting End Date:
08/25/2025 *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.

Requisition ID: R359904
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