Back to Job SearchROLE OVERVIEW
We are currently looking for a Senior Technical Specialist (Manufacturing Support) to join a leading pharmaceutical development services company. This exciting opportunity is based at our client's state-of-the-art facility, where you will play a critical role in ensuring the integrity and regulatory compliance of manufacturing processes.
In this role, you will take ownership of product and process validation activities, including leading PPQ campaigns and supporting ongoing process validation efforts for commercial products. You will collaborate with cross-functional teams to turn scientific data into reliable supply, maintain systems in a validated state, and support investigations and improvements within a GMP environment.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Senior Technical Specialist will be varied however the key duties and responsibilities are as follows:
• Own and manage product/process validation activities, including authoring and reviewing validation protocols, analyzing data, and ensuring timely completion and release.
• Lead or participate in equipment and facility qualification, applying DQ–IQ–OQ–PQ methodologies, maintaining validation lifecycle, and ensuring data integrity principles are upheld.
• Support the onboarding of new technology and processes, including generating URS, functional/technical specifications, and risk assessments in collaboration with Technical Operations and Quality.
• Manage investigations arising from deviations and change control processes, conducting relevant risk assessments and validation impact analyses.
• As the Senior Technical Specialist, you will represent equipment and process validation during audits and regulatory inspections to defend strategies and reports.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Senior Technical Specialist, we are looking to identify the following on your profile and past history:
• A Degree or higher level in a Life Science or Engineering subject (e.g., Pharmaceutical Chemistry / Engineering / Quality Assurance).
• Proven process validation experience in GMP drug product manufacturing, including leadership of PPQ campaigns and CPV activities.
• Practical knowledge of FDA PV guidelines, EU GMP Annex 15, and ICH Q8/Q9/Q10, with experience in equipment and process validation within a regulated environment.
• Strong technical writing skills and experience with validation systems such as TrackWise, including data integrity principles (ALCOA+).
WHAT’S IN IT FOR YOU?
Joining our client offers the opportunity to work within a leading pharmaceutical development organisation that values innovation and scientific excellence. You will have the chance to develop your career in a collaborative and forward-thinking environment, contributing to the delivery of high-quality medicines to patients globally. The role also provides exposure to regulatory interactions, supporting your professional growth in a highly regulated industry.
Key Words: manufacturing / validation / GMP / PPQ / equipment qualification / process development / data integrity / regulatory inspections / cross-functional collaboration / scientific excellence
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
