Overview
Job Description
A fantastic opportunity has arisen to join our Graduate Programme. By offering real and meaningful roles in the delivery of key tactical projects and initiatives, we will enable the successful candidate to develop the core competencies as outlined above.
Responsibilities
* Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications. Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT.
* Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOPs, SWIs, training documents, and change controls. Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
* Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
* Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
* Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
* 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.
* Assist in the management and/or assignment of IPT training if required.
Qualifications
* MSc/BSc. qualification (Engineering or Science or similar) or equivalent.
* High level written and verbal communications with advanced PC skills.
* Self-motivated and ability to work as part of a team
* High personal integrity, credibility and energy. Demonstrated ability to work as part of diverse teams in an inclusive manner.
* Demonstrated ability to be self-driven with respect to driving results and implementing identified improvement initiatives.
Additional Information
PQ20
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: Project Temps (Fixed Term)
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: No Travel Required
Flexible Work Arrangements: Hybrid
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): n/a
Required Skills: Analytical Problem Solving, Batch Releases, BPM, Change Management, Clinical Research, Communication, Document Management, GMP Compliance, Manufacturing Documentation, Project Management, Regulatory Requirements, and related skills.
Job Posting End Date: 09/20/2025
Requisition ID: R362989
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