Job Description

A new and exciting opportunity has come for a Validation Senior Engineering Specialist(s) on our Carlow Site with Technical Operations. You will be responsible for:

• Leadership of validation activities within the Recovery and Cleaning qualification team and across other validation teams.
• Maintaining compliance of 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, ensuring consideration of the impact on GMP and compliance and decisions made.
• Compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance.
• Supporting regulatory audits and submissions as required.
• Work collaboratively to drive a safe and compliant culture in Carlow.

What you will do:

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

The successful candidate will be involved in recovery studies, establishing and implementing acceptance criteria, cycle development, initial qualification activities for new product introductions and periodic revalidation on the Carlow site, included but not limited to the following:

• Planning, scheduling and oversight of Periodic Revalidation & Initial Qualification studies.
• Responsible for setting and delivery of validation strategies.
• Lead and supports complex & critical investigations associated with validation and commercial activities.
• Co-ordinate multiple complex projects in parallel including but not limited New Product Introductions, Process Improvements and Investigations.
• Execution of Periodic Revalidation, Cycle Development & Initial Qualification studies as required.
• Technical review and approval of Periodic Revalidation, Cycle Development & Initial Qualification protocols & reports.
• Authoring and reviewing standard operating procedures and technical reports.
• Engage in the early stages of projects.
• Act as validation SME on the equipment within the area assigned.
• Serving as a key member during internal audits and external inspections/audits.
• Implementing the requirements as outlined in the site & project Validation Master Plan(s) and periodic revalidation plan.
• Supporting regulatory submissions.
• Support continuous improvement through Lean Six Sigma methodologies.
• Make problems visible and strive for continuous improvement.
• Lead and promote various organizational initiatives as needed (examples include EHS, workload forecasting, work standardisation, etc).
• Providing technical and validation oversight to process, design and project delivery teams.
• Represent the site in internal collaborations through Manufacturing Division Communities of Practice (CoP) for Validation to include imparting of best practices in Validation and investigation activities.
• Keep up to date with scientific and technical developments, best practices and attend seminars.
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
• Within the role you will be acting as a validation engineer reporting within the Validation Engineering Team.

What skills you will need:

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

• Proven history of leadership skills within current and previous roles.
• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
• A minimum of 4-5 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• SME in Cleaning Validation for reusable parts and process vessel washing and using Automated COP and CIP systems.
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.
• Experience of coaching, mentoring and leading a team in the validation department in the past is desirable.
• Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, authoring documents subject to regulatory inspection.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Analysing and interpreting complex data.
• Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
• Experience in working in other validation areas such CTU, Isolator and Filling Lines, Sterilisation (SIP & Autoclaves), Ancillary Qualification (Filters, CCI, Shipping) is considered advantageous but not mandatory.

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):

Required Skills:

Change Management, Cleaning Validations, Cleaning Verification, Cleanroom Validation, Data Analysis, Deviation Management, Equipment Qualification, Facility Management, Good Manufacturing Practices (GMP), Maintenance Supervision, Occupational Safety and Health, Regulatory Audits, Sterile Manufacturing, Team Leadership, Troubleshooting, Vaccine Manufacturing

Preferred Skills:

Continuous Improvement, Process Improvements, Standard Operating Procedure (SOP), Validation Activities

Job Posting End Date:

07/30/2025

*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.