Job Description

We are hiring a Process Engineer / Specialist to join the Tech Ops Commercial Support Process team at our Carlow site. This is an exciting opportunity to work in a biopharma manufacturing environment supporting commercial products, commercialisation activities, and process improvement initiatives.

This role is well suited to an experienced, independent engineer who can hit the ground running, act as a technical SME, and work across a wide range of stakeholders. You will have visibility across site, above site, and global teams, with opportunities to contribute to business-critical projects, stretch assignments, and continuous development.

Role Responsibilities

Coordinate, execute and document qualification, process studies, and related product programmes.
Provide technical support for commercial manufacturing, including technical impact assessments.
Own and manage change controls and related compliance commitments.
Perform data analysis using PDM/DataLynx and other relevant systems to support process understanding and decision-making.
Use MES, Pi, and automation systems to monitor, control and optimise process performance.
Conduct and support Quality Risk Assessments (QRA) in line with site and corporate standards.
Support and maintain CPV (Continued Process Verification) and PPM (Proactive Process Monitoring) systems to ensure ongoing process performance and product quality.
Ensure audit readiness, including preparation, documentation and interaction with auditors.
Generate, review and approve process documentation in line with cGMP, QMS and regulatory requirements.
Lead and support investigations, troubleshooting, and deviation resolution.
Represent Technical Operations in cross-functional meetings and provide technical expertise as required.
Ensure compliance with QMS and relevant standards, proactively identifying and escalating compliance risks.
Drive continuous improvement using MPS / Lean tools and contribute to problem-solving and project work.
Lead business-critical projects and process initiatives for Technical Operations.
Demonstrate strong communication and teamwork to support a safe, compliant and high-performing culture.
Continuously develop technical capability and provide mentoring/guidance where appropriate.
Apply understanding of key business drivers to day-to-day activities.
Perform other duties as required.

What skills you will need

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

A Bachelor’s degree or higher in Science, Engineering, or another technical discipline.
4–5+ years’ experience in a manufacturing environment, preferably GMP, with experience in aseptic manufacturing and/or process engineering.
Demonstrated experience in:
- Managing change control projects
- Completing technical impact assessments on commercial products
- Performing data analysis using PDM/DataLynx and presenting findings to site and global functions as required
- Working with MES, Pi, and automation systems
- Supporting/ leading QRA
- Supporting CPV and PPM systems
- Maintaining audit readiness
Strong knowledge of relevant Irish, European, and international regulatory requirements, codes and standards.
Excellent technical writing skills, including reports, standards, policies and protocols.
Familiarity with sterile filling processes and equipment.
Proficiency in Microsoft Office and other job-related applications.
Strong communication, presentation and interpersonal skills, with the ability to work effectively across all levels and with external partners.
Experience with Lean Six Sigma methodology is preferred.

The following would be advantageous:

Experience with data analytics systems
Knowledge of QRM and integrated risk management
Background in fill-finish / sterile injectables
Experience with MES / SAP and deviation management systems
Experience drafting protocols in Kneat / similar system/s
Experience in medical devices may also be considered if the required skills are met

Our facility in 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.

Required Skills:

Application Monitoring, Application Monitoring, Applied Engineering, Audit Preparations, Biopharmaceutical Operations, Business Process Management (BPM), Change Control Processes, Change Management, Data Analysis, Equipment Qualification, GMP Compliance, GMP Guidelines, GMP Validation, Maintenance Supervision, Manufacturing Environments, Manufacturing Process Improvements, Manufacturing Support, Process Optimization, Process Qualification, Regulatory Compliance Consulting, Regulatory Requirements, Risk Management, Sterile Processing, Teamwork, Technical Calculations {+ 2 more}

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:

Hybrid

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

NA

Job Posting End Date:

06/5/2026

*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.