Technical Operations Lead

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 validationPackaging process validationCleaning validationEquipment qualificationFacility and computerised system validationProvide 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 RequirementsDegree 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 RequirementsProcess 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 InformationThis 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.