Job Description

We are seeking a Compliance Engineer to join our Engineering Department at our Carlow site, supporting operations in a GMP and Sterile Environment. This role is essential for ensuring compliance, safety, and reliable product supply. Key responsibilities include generating and expediting the review of Manufacturing GMP documentation such as deviation reports (QNs) and corrective and preventative actions (CAPAs), supporting global audit readiness, and participating in audits. The Compliance Engineer will also author, edit, and review controlled documents, collaborate within cross-functional teams to solve problems using Root Cause Analysis (RCA) methodologies, and ensure timely completion of documentation to maintain compliance with regulatory requirements.

What you will do:

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

Direct and/lead deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective actions.Preparation and analysis of Engineering metrics reports to trend for improved operational efficiencies.Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so.  Documents will include SOP’s, SWI’s, training documents, JSA’s, PM's and change controls.Accountable for leading investigation analysis, identifying true root cause, identifying gaps and actions to close gaps. Collaborate with Engineering colleagues and other departments particularly IPT, Quality, EHS, Technical Engineering in completion of tasks.Required to comply with Global   Policies, Procedures   and   Guidelines,  regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned.Support Audit Readiness activities.

What skills you will need:

In order to excel in this role, you will more than likely have:

Diploma or higher preferred, ideally in a related discipline.Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting.Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environmentKnowledge of regulatory/code requirements to Irish, European and International Codes, Standards and PracticesReport, standards, policy writing skillsSterile filling processes and equipment experience preferred.Proficiency in Microsoft Office and job-related computer applicationsLean Six Sigma Methodology experienceEffective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customersUnderstand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes ones department supportsEffective time management and multi-tasking skillsProven organizational skillsExcellent attention to detail

At our company, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from Ireland to the world.

Our Commitment to Ireland:

Our Company Ireland is one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of the company’s top products, helping save and enhance lives in over 140 countries around the world.

The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics, and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories, and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

As a company, we are committed to ‘Inventing for Life’ in all that we do. 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. 

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, 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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/26/2024

*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:R322486