At a Glance
- Tasks: Lead process validation and support new product transfers in a dynamic pharmaceutical environment.
- Company: Join a growing pharmaceutical manufacturing organisation with a focus on innovation.
- Benefits: Full-time, permanent role with opportunities for professional growth and development.
- Other info: Collaborative culture with a focus on continuous improvement and compliance.
- Why this job: Make a real impact in the pharmaceutical industry while working with cutting-edge technologies.
- Qualifications: Degree in Science, Pharmaceutical or Engineering; experience in GMP-regulated environments.
The predicted salary is between 38250 - 46750 £ per year.
Technical Operations Lead
Location
Northern Ireland
Type
Full Time, Permanent
The Opportunity
We are seeking an experienced
Technical Operations Lead to join a growing pharmaceutical manufacturing organisation.
This is a key technical role supporting the transfer of new products into commercial manufacturing, while also providing ongoing lifecycle support for established products.
The successful candidate will bring strong expertise in process validation, technology transfer, GMP compliance, and manufacturing support , working cross-functionally across Pharmaceutical Development, Technical Services, Engineering, Quality, Regulatory Affairs and Manufacturing Operations.
Key Responsibilities
- Lead and support process validation activities across development and commercial manufacturing programmes.
- Prepare, review and approve validation protocols, reports, SOPs, master plans and supporting technical documentation.
- Collaborate with Process Development, Technical Services, Engineering, Health & Safety and Quality teams to establish robust process control strategies.
- Support equipment qualification activities, process performance qualification (PPQ) studies and associated risk assessments.
- Review manufacturing process documentation to ensure alignment with approved formulations and regulatory submissions.
- Provide technical expertise during investigations relating to deviations, CAPAs, out-of-specification (OOS) and out-of-trend (OOT) results.
- Support the introduction of new products into manufacturing and provide technical oversight throughout technology transfer activities.
• Act as a subject matter expert for validation activities, including
- Manufacturing process validation
- Packaging process validation
- Cleaning validation
- Equipment qualification
- Facility and computerised system validation
- Provide technical support to Regulatory Affairs on validation-related matters.
- Participate in project and customer meetings to ensure projects remain aligned with agreed timelines and objectives.
- Support scale-up activities from development through to commercial manufacture.
- Identify and implement continuous improvement initiatives focused on process efficiency, yield improvement, cycle time reduction and cost optimisation.
- Ensure all activities are conducted in compliance with current GMP requirements, EHS standards and applicable regulatory expectations.
- Maintain awareness of current international regulatory guidance and industry best practices relating to process validation.
Essential Requirements
- Degree qualified in a Scientific, Pharmaceutical, Engineering or related discipline.
- Experience working within a GMP-regulated pharmaceutical or life sciences environment.
- Practical experience of process validation and associated regulatory requirements.
- Experience authoring and reviewing technical documentation, including protocols and reports.
- Strong understanding of data interpretation, investigation processes and risk-based decision making.
- Working knowledge of VICH guidelines.
- Proficient in Microsoft Office applications.
Desirable Requirements
- Process Engineering or Chemical Engineering background.
- Experience supporting technology transfer and scale-up activities.
- Previous experience transferring products from development into commercial manufacture.
- Experience across multiple pharmaceutical dosage forms.
- Additional experience within pharmaceutical development, technical services or manufacturing support functions.
- Additional Information
- This manufacturing facility handles penicillin products. Therefore, the role may not be suitable for individuals with a penicillin allergy.
- Applicants must have the right to work in the UK at the time of application.
Technical Operations Lead in Dartford employer: Next Phase Recruitment
Join a dynamic and innovative pharmaceutical manufacturing organisation in Northern Ireland, where your expertise as a Technical Operations Lead will be valued and impactful. We foster a collaborative work culture that prioritises employee growth through continuous learning opportunities and cross-functional teamwork, ensuring you thrive in your career while contributing to meaningful advancements in healthcare. Enjoy the unique advantage of working in a state-of-the-art facility that champions compliance and quality, all while being part of a supportive community dedicated to excellence.
