Validation Technician
Validation Technician
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1 Vacancy
Job Description
Job Description
- 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.
- Bachelors degree in a relevant science or engineering discipline.
- 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.
- 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.
- 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 ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Applied Engineering cGMP Regulations Management Process Manufacturing Validation Activities Validation ProtocolsPreferred Skills:
Job Posting End Date:
10/11/2025*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.
Required Experience:
IC
Employment Type
Full-Time
