Skills: Regulatory Compliance
Education: Associates/2 yr Degree/Diploma
Location: Ware, United Kingdom
Wood Pharmaceutical & Life Sciences business are currently recruiting for a Validation Engineer to support on the delivery of an EPC framework contract on a large pharmaceutical site.
This is a full time, permanent position and you will be based on the client site at Ware, Hertfordshire.
Responsibilities and Duties
- Organise validation activities in order to provide an effective validation service.
- Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives.
- Present & justify validation scope and documents
- Review and approve documentation and reports supporting the validation exercise.
- Ensure that both team and key customers are kept informed of changes to validation requirements.
- Definition of the commissioning and qualification strategy (incl. Development of System Impact Assessment, Validation Master Plan, C&Q schedule)
- Formal GMP reviews during Concept, Scheme and Detailed Design phases
- Risk Assessment for GMP Systems
- Design Qualification (with Traceability Matrix) for GMP Systems
- Review of FAT protocols, execute and witnessing of FAT
- Review of Vendors' SAT protocols
- Preparation of Commissioning protocols
- Preparation of IQ/OQ protocols
- Review of IQ/OQ protocols prepared by equipment Vendors
- Coordination/witness to SAT/Commissioning tests executed by Vendors/Contractors
- Review of executed SAT/Commissioning protocols
- Coordination/execution/witness to IQ/OQ tests executed by Vendors/Contractors
- Execution of FAT, SAT and IQ/OQ
Skills / Qualifications
- Qualification in a Scientific / Engineering discipline or relevant NVQ/SVQ/HNC/HND, with at least 3yrs experience
- Good knowledge of GMP within a Pharmaceutical Environment
- Advanced knowledge of the following:
- Facility Validation
- CSV/ IT Validation
- Equipment Validation
- Cleaning Validation
- Effective communication skills and ability to communicate and influence at most levels of management
- Ability to build networks, to secure buy in and support for plans and ideas
- Exposure to working within a technical environment.
- Excellent interpersonal organisational, communication and team building skills.
- Excellent verbal/written communication, problem solving, and decision-making skills.
- Computer literate.
- Fully conversant with regards to discipline technical knowledge.
- Proven experience of interpreting discipline documentation.
- Ability to work with timelines/targets.
- Display both good judgment and leadership qualities.
- Ability to be assertive and drive culture change when required.
- Ability to monitor work progress and report against the plan.
Wood is a global leader in engineering and consultancy across energy and the built environment, helping to unlock solutions to some of the world's most critical challenges. We provide consulting, projects and operations solutions in more than 60 countries, employing around 40,000 people. www.woodplc.com
We are an equal opportunity employer that recognises the value of a diverse workforce. All suitably qualified applicants will receive consideration for employment on the basis of objective criteria and without regard to the following (which is a non-exhaustive list): race, colour, age, religion, gender, national origin, disability, sexual orientation, gender identity, protected veteran status, or other characteristics in accordance with the relevant governing laws.
Wood is a global leader in consulting and engineering across energy and the built environment, helping to unlock solutions to some of the world’s most critical challenges. We provide consulting, projects and operations solutions in more than 60 countries, employing around 40,000 people. At Wood our common purpose is to ‘unlock solutions to the world’s most critical challenges.’ Through the delivery of our Consulting, Project and Operations solutions across energy and the built environment we deliver exceptional returns for our clients, our people, our investors and the communities where we live and work. Visit us at www.woodplc.com and follow us on Facebook and LinkedIn.