Job Description
A new and exciting opportunity is now available on our Carlow Site for a Manager for New Product Introductions. The successful candidate will join the Technical Operations Group on site and report to NPI Coach. The NPI Manager will serve as technical support for new product introduction (NPI) and commercial manufacturing.
Key responsibilities will include:
1. Design/Author/Review/Approve/Execute process development studies.
2. Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
3. Will typically have prior related work experience; ideally in manufacturing, preferably GMP Setting.
4. Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
5. Execution/development of change controls.
6. Technical input into quality notification by authoring/reviewing/approving investigations.
7. Execution of equipment/qualification validation programs; including re-qualification and re-validation.
8. Support continuous improvement through Lean Six Sigma methodologies.
9. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
10. Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums.
11. Drive compliance of company 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.
12. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
13. Work collaboratively to drive a safe and compliant culture.
14. May be required to perform other duties as assigned.
Your profile:
1. Bachelor's Degree or higher preferred; ideally in a Science, Engineering, or other technical discipline.
2. Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
3. Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity.
4. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
5. Reporting and policy writing skills required.
6. Equipment and process validation experience.
7. Sterile filling processes and equipment environment experience.
8. Proficiency in Microsoft Office and job-related computer applications required.
9. Project management, risk management and strong change management experience.
10. Ability to effectively manage complex projects across multiple disciplines.
11. Progressive people management skills.
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: 04/14/2025
*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.
Requisition ID: R341912
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