Assoc. Spclst, Engineering
Assoc. Spclst, Engineering
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Job Description
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.
Bring energy knowledge innovation to carry out the following:
- 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 CAPAs and conduct investigations. Raise and investigate quality notifications using standard tools and methods to resolve system issues e.g. FMEA Fishbone diagrams 5 whys 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 require
What skills you will need:
In order to excel in this role you will more than likely have:
- 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.
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 relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Analytical Problem Solving Analytical Problem Solving Batch Releases Business Process Management (BPM) Change Management Clinical Research Communication Corrective Action Management Data Analytics Database Management Data Entry Data Visualization Document Management GMP Compliance Good Manufacturing Practices (GMP) Health Economics Management Process Manufacturing Compliance Manufacturing Documentation Office Applications Process Flow Documentation Process Improvements Production Support Project Management Regulatory Requirements 4 morePreferred Skills:
Job Posting End Date:
09/20/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Employment Type
Full-Time
