Our client is looking to appoint an experienced Project Validation Technician to help deliver their extended business portfolio of project services and further support our clients and suppliers, we have created an exciting opportunity.
In this role, you will be responsible for providing project, technical, scientific and validation support across the business and directly to our network of customers and suppliers. As a CQV team member, you will support the delivery of equipment, process, validation, and business projects. This role provides the right candidate with an exciting opportunity to work ‘hands-on’, across an extensive range of project services and an array of equipment and process types.
Key Responsibilities
- Responsible for direct customer support and OPEX project management - liaise between all parties during OPEX equipment build and report on, so that agreed timescales are respected, all parties are kept aware of the progress achieved and planned.
- Completion of project documentation and tasks in line with our business’s internal templates, processes and GPG’s.
- Management & completion of said tasks (e.g. Protean) & providing the contract managers (TSE’s) with information to ensure invoices raised for site work performed in timely manner.
- Organise shipping as required, monitor progress, and keep customer advised of likely delivery date(s).
- Supporting planning and sitework activities.
- Responsible execution of delegated project services (such as RTM, technical reviews, reports, and other technical & commercial opportunities).
- Provide technical writing support to our wider team, our suppliers, and our customers.
- Reasonable Supplier & Customer support visits as deemed necessary – e.g. FAT validation support, project, or validation meetings.
- Punchlist management across all equipment supply.
- ~25% ‘On site’ execution of validation documentation including protocols, summary reports & other lifecycle documents, as required.
- Co-ordinating & supporting validation testing of equipment such as autoclaves, process & utilities.
- Analysing, interpretation and reporting on validation testing against acceptance criteria.
- Supporting the Team in other value add deliverables, such as HAZOP, FMECA, other similar activities.
- Be accountable, customer focused & collaborative. At all times, this person needs to reflect the company’s goals and values.
- Contribute to business initiatives & actions (e.g. quality system, technical research, improvements & promotion, continuous improvements, health & safety).
- Other duties as assigned.
Key skills and experience
- Project management experience.
- Having the right attitude and drive to meet objectives and targets.
- Reasonable travel to customer and supplier sites will be required.
- Technical writing. An excellent understanding of ‘Plain English’ writing technique.
- Relevant Degree or comparable qualification in an engineering, science, or validation discipline.
- Having relevant experience supporting aseptic manufacturing or clean utilities would make you a great addition to the team.
- Ability to read and interpret documents such as technical drawings, process specifications, safety protocols, company policies, and procedure manuals.
- Demonstrate a structured approach to documentation planning & design.
- A demonstrated clear understanding of equipment validation lifecycles in the pharma industry.
- Being able to work on your own initiative, to pre-determined schedules, and execute validation studies.
- Ability to successfully manage concurrent deliverables on time.
- Be able to converse with, present on and interrogate customer/supplier validation requirements.
- Ability to analyse and organise complex material. Attention to detail.
- A demonstrated proficiency in the standard MS packages.
- Organised, adaptable & flexible.