At a Glance
- Tasks: Support pharmaceutical development with study design, reporting, and problem resolution.
- Company: Leading pharmaceutical company focused on innovation and compliance.
- Benefits: Generous annual leave, healthcare plan, pension scheme, and employee perks.
- Other info: Great career development opportunities and a supportive work culture.
- Why this job: Join a dynamic team and make a real impact in pharmaceutical process validation.
- Qualifications: Degree in a scientific discipline and experience in a cGMP environment.
The predicted salary is between 38250 - 46750 £ per year.
Job ref: SDPV110826
Job type: Permanent
Location: Newry
Closing date: Tuesday 25 Aug 2026 17:00
Main Activities/Tasks
- Technical support to the pharmaceutical development team to aid in both study design/reporting and in problem resolution.
- Compile and review protocols, reports, SOPs and Master Plans ensuring that they comply with GMP and safe working practices.
- Collaborate with Process Development/Tech Service Team/H&S/Engineering to influence the design and implementation of a robust process control strategy, provide process risk assessments and associated documentation to support equipment qualification activities, PPQ studies and key technical strategies and to provide compliance with the current TT SOP.
- Review PCRs generated for use in the production facility and ensure in line with the proposed manufacturing process as defined by Formulations or Regulatory Submission.
- Ensure that Out of Specification and Out of Trend results are fully investigated in line with the company's SOPs and Quality Management System.
- Maintain an awareness of current guidelines in UK/Ireland, EU, US and ROW in relation to industry best practice for Process Validations activities.
- Provide technical support to the regulatory department, where required, on all matters concerning PV studies undertaken by the Pharmaceutical Development Team.
- Participate in due diligence initiatives by acting as the subject matter expert for technology evaluation and all types of validation and work with colleagues in relation to validation of Facilities and Computerized Systems.
- Provide technical support to Manufacturing Operations through provision of expertise for investigation and resolution of process deviations, CAPAs, review and approval of change controls associated with New product introduction.
- Provide technical input and evaluation for GMP Investigations from the manufacturing facility.
- Oversee with hands-on involvement in batch manufacturing for development, pre-approval, engineering and pre-market commercial scale batches.
- Ensure compliance with EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations.
- Ongoing technical support of Manufacturing Operations by providing technical expertise for investigation and resolution of process deviations, CAPAs, review and approval of change controls.
Essential Criteria:
- A degree in a scientific discipline.
- Previous experience working in a cGMP environment.
- Working knowledge of VICH guidelines.
- Practical working knowledge of process validation.
- Experience in the compilation of protocols, reports and interpretation of raw data.
Desirable Criteria:
- A process / chemical engineering background.
- 2+ years' experience in a cGMP environment.
- Previous relevant experience in Process Validation and scale-up within a pharmaceutical company.
- Previous practical experience of scale-up from development to routine manufacture.
- Experience in scale-up of various pharmaceutical dosage forms.
Benefits:
- Free life assurance.
- Company pension scheme.
- Healthcare cash plan.
- 32 days annual leave.
- Wedding leave.
- Company sick pay.
- Employee well-being initiatives.
- Employee assistance programme.
- On-site free parking.
- Subsidised canteen facilities.
- WeCare programme - supporting the local community.
- Employee perks scheme.
- Employee recognition scheme.
- Career development opportunities.
To Apply
Please forward your CV via the APPLY Now button below.
Study Director - Process Validations TLNT1_NI in Newry employer: Norbrook
As an MS&T Site Manager at our Newry location, you will be part of a dynamic and supportive work culture that prioritises employee development and safety. We offer competitive benefits, including opportunities for professional growth and a commitment to maintaining the highest quality standards in manufacturing. Join us to make a meaningful impact while enjoying a collaborative environment that values innovation and teamwork.
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We think you need these skills to ace Study Director - Process Validations TLNT1_NI in Newry
Some tips for your application 🫡
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How to prepare for a job interview at Norbrook
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Norbrook that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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