Validation Technician Borehamwood, England
Job description
Bio Products Laboratory (BPL) have a new and exciting opportunity for a Validation Technician to join our manufacturing facility at Elstree, Hertfordshire.
BPL manufactures pharmaceutical products derived from human blood plasma. These products are used to treat patients for conditions such as immunodeficiencies, coagulation disorders and critical care (blood volume deficiency).
This vacancy is double days shift - Monday to Friday only, 6am to 2pm, 2pm to 10pm, rotating weekly.
As part of the Process Validation team, you will be actively involved in all aspects of service delivery relating to process validation within your remit. You will ensure compliance with all applicable (EHS and GxP) regulatory and internal Quality standards and industry best practice. Be committed to, and passionate about, providing a reliable and compliant service to meet and exceed the customer’s needs.
This is a customer-facing role, and as such the ability to form relationships across the organisation is essential for success.
Key Duties and Responsibilities:
- Ensure you and the personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.
- Collective responsibility for the ongoing compliance of all assets at the Elstree facility within your remit, ensuring that the equipment meets regulatory requirements at all times with a target of zero impact to routine operations.
- Maintain an ongoing dialogue with Validation Specialists/Management to ensure validation resources are effectively deployed to meet dynamic and competing business priorities.
- Support the implementation validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.
- Highlight risks to product quality, patient safety and/or data integrity throughout the validation lifecycle so that they are understood, transparent and can be managed through the application of a quality risk management approach.
- Develop an appreciation for the use of risk and science based tools to drive execution strategies and support issue resolution.
- Identify skills and competency development needs within the team. Support individual and team development through the Elstree training processes.
- Support Validation Management in the identification, recruitment and on-boarding of resource (staff and contract) into the organisation.
- Ensure that the performance of the personnel (internal and external) operating under your remit meets the standards (competence and behavioural) required by BPL.
- Participate in commissioning, qualification and validation implementation within your remit and, in conjunction with your peer group, across the validation team to ensure consistent service delivery and systemic application of process improvements.
- Directly assist the Validation Specialists/Management in ensuring that adequate budget (opex and capex) is planned and spent in support of the validation team.
- Contribute towards the validation team’s state of inspection readiness at all times and preparation of validation packages for presentation to regulatory authorities.
- Escalation to Validation Specialists/Management, at the earliest opportunity, when issues or obstacles that impact compliance or on time delivery.
- All other tasks and duties, as necessary, to maintain the effectiveness of the validation service as required by the business and/or Validation Specialists/Management.
Experience and attributes to make you successful in the role:
- Degree level qualification, science or engineering discipline or equivalent.
- The job holder is expected to demonstrate a willingness to engage in self-directed learning, an ability to assimilate new information into their routine working practices and a desire to develop their level of experience and expertise with the aim of developing towards a more senior role.
- A natural tendency towards continuous improvement is required. It is an expectation that Validation processes evolve both to assure best practices and to maximise the efficiency of site resources.
- Excellent documentation skills.
- Experience of validation within a parenteral (bio)pharmaceutical or blood products manufacturing environment (API and/or fill/finish) would be an advantage.
In return we offer -
- Competitive salary, and benefits to include a performance related bonus
- Pension
- Life Insurance
- 25 days holiday
- On-site parking and a subsidised restaurant
BPL aspire to be the leader in our field since privatising from the NHS in 2013, BPL has gone through huge change and growth. We are an organisation where our products change people’s lives, and the purpose of our work is lived and breathed through its people.
Please apply today for immediate consideration.
