Job Description

A fantastic opportunity has arisen for an Associate Technical Specialist.

The Associate Specialist, Engineering, Technical Operations, Q&V will be an active member within the cross functional team providing support and guidance and will strive for technical excellence to ensure the success of the Q&V team.

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

Lead/Execute/Participate in Equipment and System Validation Lifecycle processes, Qualification (IQ/OQ/PQ), Revalidation, Requalification and Equipment Periodic Reviews, for Equipment and Systems.Coordinate with and guide other departments or outside contractors/vendors to complete validation tasks.Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements,.Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.Execute/Participate in change controls and other compliance related tasks e.g. non-conformances.Support regulatory auditsLead/Support Shipping Qualification and/or Cleaning Verification/Validation activitiesWork on own initiative to maintain adherence to schedule of activities including run the business and project workloads.Support, lead or guide others in CQV projects

What skills you will need:

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

Hon. Degree in a Science or Engineering discipline.Experience in a GMP environment essential.1-2 years’ experience in a similar role.Demonstrated knowledge in pharmaceutical/biopharmaceutical technical manufacturing operations, with experience of successfully delivering technical projects.Knowledge of Regulations and applicable standards for Quality, Safety, RegulatoryDemonstrated high level of problem solving and attention to detail.Demonstrated capability of working and collaborating across multiple functional teams.Demonstrated capability to deliver results RFT, in an FDA/HPRA Regulated production environment.Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels

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.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, 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:

Adaptability, Adaptability, Biopharmaceutical Industry, Biopharmaceutical Operations, Business, CAD Proficiency, Compliance Strategies, Cross-Functional Teamwork, Data Analysis, Engineering Principle, Engineering Standards, Estimation and Planning, Experimentation, GMP Compliance, Management Process, Problem Solving, Process Optimization, Production Control, Professional Engineering, Project Management, Quality Management System Auditing, Social Collaboration, Software Proficiency, Stakeholder Management, Stakeholder Relationship Management {+ 5 more}

 Preferred Skills:

Job Posting End Date:

06/6/2025

*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.

Requisition ID:R350555