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Validation technician

Milton Keynes
Merck Gruppe - MSD Sharp & Dohme
Technician
Posted: 29 September
Offer description

About us

Join a dynamic pharmaceutical manufacturing team committed to delivering safe, high-quality medicines. We combine scientific rigour with continuous improvement to maintain world-class manufacturing standards. If you enjoy hands-on validation work, problem-solving and influencing best practice across a production environment, this role is for you.


The role

As a Validation Technician you will manage, drive and support initial validation activities and periodic revalidation across our Manufacturing Division, ensuring ongoing compliance with current Good Manufacturing Practice (cGMP). You will be a key contributor to new projects, process changes and routine requalification activities, ensuring robust, documented evidence that our facilities, utilities, equipment and computerized systems perform reliably and safely.

This is a fixed term role.


Key responsibilities

* Develop and execute validation plans for projects and changes to processes, equipment, utilities, computer systems and facilities.
* Prepare, review and approve validation protocols, qualification reports, plans, quality risk assessments and related documentation.
* Ensure adherence to the requalification plan and maintain compliance with cGMP and company quality standards.
* Raise, investigate and close deviations and CAPAs; support investigations into events as required.
* Conduct or support testing and validation activities for HVAC/HEPA systems, clean rooms, isolators, biological safety cabinets, autoclaves, aseptic simulations, sterile filtration, manufacturing equipment, controlled temperature units and laboratory methods.
* Perform or oversee airflow visualisation studies (AVS), environmental monitoring and other validation-specific tests.
* Use validation tools and instruments (data loggers, DOP testing equipment, AVS kit, anemometers, balometers) and interpret results.
* Manage and coordinate external contractors as required.
* Maintain up-to-date knowledge of cGMP, company quality manuals and relevant regulations and guidance.
* Identify opportunities for improvement and lead solutions through to implementation and closure.


What we’re looking for


Qualifications

* Bachelor’s degree in a relevant science or engineering discipline.


Experience

* Experience in validation, quality, production or engineering within the pharmaceutical industry.
* Demonstrated hands-on experience with validation and requalification activities across a wide range of systems and equipment, including but not limited to: HVAC/HEPA, clean rooms, isolators and containment devices, AVS, autoclaves, sterile filtration, manufacturing processes, utilities (steam, compressed air, nitrogen, PW/WFI), CIP/cleaning processes, controlled temperature units and laboratory methods.
* Experience working with computerized systems and common validation software/spreadsheets.
* Practical experience using validation equipment (temperature/pressure data loggers, DOP testers, AVS equipment, anemometers, balometers).
* Experience managing external contractors is desirable.
* Solid understanding of cGMP and good documentation practices.


Skills and attributes

* Strong attention to detail and the ability to review and correct technical documentation.
* Excellent verbal and written communication skills; able to prepare clear, compliant reports and interact effectively with multidisciplinary teams.
* Collaborative team player with a proactive, professional attitude and high personal integrity.
* Strong decision-making and analytical skills; able to assess issues from multiple angles and deliver well-reasoned conclusions.
* Effective planning, prioritisation and time-management skills to meet deadlines and produce quality deliverables.
* Comfortable driving change through coaching, influencing and mentoring.
* A continuous-improvement mindset with the ability to identify and implement practical solutions.


Why join us

* Work on meaningful projects that directly impact product quality and patient safety.
* Supportive, inclusive team culture with opportunities for professional development.
* Competitive salary and benefits package including [list key benefits: pension, healthcare, flexible working, training, etc.].
* Modern facilities and opportunity to work with industry-standard validation equipment and techniques.

Closing date for applications: 10/10/2025

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: Temporary (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills: Applied Engineering, cGMP Regulations, Management Process, Manufacturing, Validation Activities, Validation Protocols

Preferred Skills:

Job Posting End Date: 10/11/2025

Requisition ID: R367353

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