Job ref: SDPV150526Job type: PermanentLocation: NewryClosing date: Friday 29 May 2026 11:00Main Activities/TasksTechnical support to the pharmaceutical development team to aid in both study design/reporting and in problem resolutionCompile and review protocols, repots, SOPs and Master Plans ensuring that they comply to GMP and safe working practicesCollaborate 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 SOPReview PCR's generated for use in the production facility and ensure in line with the proposed manufacturing process as defined by Formulations or Regulatory SubmissionEnsure that Out of Specification and Out of Trend results are fully investigated in line with the company's SOP's and Quality Management SystemTo maintain an awareness of current guidelines in UK/Ireland, EU, US and ROW in relation to industry best practice for Process Validations activitiesProvide technical support to the regulatory department, where required, on all matters concerning PV studies undertaken by the Pharmaceutical Development TeamParticipate 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 introductionProvide technical input and evaluation for GMP Investigations from the manufacturing facilityOversee with hands-on involvement in batch manufacturing for development, pre-approval, engineering and pre-market commercial scale batchesEnsure compliance with EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigationsOngoing technical support of Manufacturing Operations by providing technical expertise for investigation and resolution of process deviations, CAPAs, review and approval of change controlsEssential Criteria:A degree in a scientific disciplinePrevious 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 dataDesirable Criteria:A process / chemical engineering background2+ 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 assuranceCompany pension schemeHealthcare cash plan32 days annual leaveWedding leaveCompany sick payEmployee well-being initiativesEmployee assistance programmeOn-site free parkingSubsidised canteen facilitiesWeCare programme - supporting the local communityEmployee perks schemeEmployee recognition schemeCareer development opportunitiesTo Apply Please forward your CV via the APPLY Now button below.WHJS1_NI