Validation Specialist
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Position Overview & Specifications
- Based in beautiful West Wales
- Up to £30k + up to 10% bonus, private healthcare etc.
- Permanent role
Validation Specialist | Ceredigion - Pharmaceutical
Permanent role
Up to £30k + up to 10% bonus, private healthcare etc.
THE ROLE…
- To deliver all validation activities to support manufacturing at our clients Wales site, ensuring all goods manufactured and services provided by the Company meet the quality requirements of the Company, customers and regulatory authorities
- Accountable for the efficient and timely delivery of Validation activities with respect to qualification of new and existing facilities, utilities, products, processes, manufacturing, packaging and computerised systems
- Responsible for the generation and approval of all validation documentation including but not limited to; installation, operation and performance qualifications, Validation plans and reports.
- Execution of validation testing for manufacturing equipment, utility systems equipment, processes, cleaning validation, product hold times, and any other study identified in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.
- To follow all Standard Operating Procedures (SOP’s), Quality Records (QRs) and Batch Manufacturing Records (BMRs) and to participate in the generation, completion and review of such documentation when required, to agreed timelines.
- Responsible for ensuring that the SVMP qualification schedule for the site is maintained in compliance at all times.
- Supporting the Validation Lead for all Regulatory Inspections, and contributing to any required validation responses from regulatory findings during site inspections.
WHAT YOU WILL NEED…
- Degree in an appropriate scientific discipline or equivalent.
- Strong technical background, gained from a highly regulated environment: pharmaceutical, biotechnology or related industry.
- Previous experience within a validation role essential.
- Provide a sound understanding of the validation and qualification requirements of manufacturing equipment qualification, computer systems validation, utility systems qualification or process validation.
- Excellent understanding and hands–on working knowledge of cGMP, quality and regulatory requirements for commercial material.
- Demonstrated knowledge of cGMPs, MHRA, FDA regulations and current industry practices.
- Experience of front line involvement with Regulatory Inspections.
WHY YOU WILL LOVE WORKING HERE….
- Fantastic company culture
- Work Monday- Friday
- Excellent bonus structure
- Private healthcare, great pension and paid maternity / paternity pay etc.
- Supportive management
- Great location - near the countryside and coast!
IND123
#sunnyjobs
Candidate Selection & Onboarding Process
Application & Resume Screening
Submit your tailored CV/Resume directly to the talent acquisition portal.
Technical & Competency Interviews
Virtual interviews with the hiring manager and multidisciplinary team.
Formal Offer & Benefits Negotiation
Written agreement outlining compensation, equity, retirement vesting, and relocation allowances.
Onboarding & Corporate Integration
Equipment provisioning, team orientation, and commencement of duties.
United Kingdom Right to Work & Skilled Worker Visa Guide
Employment in the United Kingdom requires legal Right to Work verified under the Home Office Points-Based Immigration System:
Sponsoring employers must hold an active Home Office A-rated Sponsor License and assign a valid Certificate of Sponsorship (CoS). Role must meet the general minimum salary threshold (£38,700) or occupation going rate.
Continuous employment under Skilled Worker status establishes eligibility for Indefinite Leave to Remain (ILR) after 5 continuous years, leading to British Citizenship.
Candidate Preparation Blueprint: General
Based on transatlantic hiring benchmarks for Validation Specialist roles across Sunny's corporate sector, successful applicants typically excel across three core dimensions:
Demonstrated portfolio evidence, architecture/system design case studies, or validated professional certifications directly applicable to General.
STAR method competency responses highlighting cross-functional leadership, conflict resolution, and delivering measurable enterprise ROI under tight timelines.
Total compensation expectation aligned within the benchmarked £30,000 - £30,000 bracket, including retirement vesting and health parity.
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