Senior Validation Specialist - Biotech
- Experience Level
- Experienced (non-manager)
Compass Life Sciences are working in partnership with a rapidly expanding biotech that are developing cutting edge therapies to support a range of diseases including securing significant institutional funding to develop a UK based COVID19 vaccine.
Our client has a number of openings for Senior Validation Specialists to support both the definition and performance of validation activities, ensuring these are compliant with EU and FDA regulatory requirements and guidelines. These are key roles to support the role out of new vaccines for a range of diseases including COVID19.
Acting as a subject mater expert for regulatory inspections as appropriate reflecting validation activities, you will provide key expertise to support the advancement of development and manufacturing of new vaccines. You will report to the Head of Validation and be part of an expanding team based in our clients new state of the art facilities in Scotland's central belt.
Key responsibilities for these roles include;
Assist in the operational validation activities, including physically performing Equipment and Facility Qualifications.
Identify areas of improvement for validation systems/procedures and to provide support with the implementation of such improvements.
Generate and complete validation documentation in accordance with relevant Standard Operating Procedures, including but not limited to:
Participate in project groups, set acceptance criteria and define the data requirements necessary to ensure that validation work is compliant.
Ensure that the Head of Validation and other key stakeholders are informed of validation matters which may have an adverse impact on the validation status of facilities, equipment systems, the manufacturing process on product disposition (e.g. batch/lot release decisions).
Investigate and report Quality Issues, escalating to management as required.
Compile key quality data for the validation program and to make such data available to management to drive a culture of continuous improvement that is fully compliant with current EU/FDA regulations and quality requirements and business needs.
To keep up to date with current guidelines and regulatory requirements in respect of internal and external quality requirements.
To provide and/or coordinate training in validation related procedures/concepts as appropriate to meet business needs.
Provide support during internal/external and third-party audits.
To be considered for this role, our client is looking for talent that have experience and a strong comprehension of Validation within a GMP environment within the biopharmaceuitical / pharmaceutical sector. Our client is also looking for;
HND level or equivalent qualification in relevant subject.
Working knowledge of Equipment Qualification and/ or Facility Qualification in a biopharmaceutical or pharmaceutical GMP environment.
Working knowledge of validation principles in at least one of the following:
Validation of aseptic processes (including filling),
Validation of Computerised systems,
Process Validation, Assay Validation, and Cleaning Validation.
Experience in regulatory inspections.
If you have strong communication skills and are able to work closely with stakeholders at all levels of seniority, this is a role in which you can have a significant impact in the development of a range of life saving, and highly relevant vaccines, in state of the art facilities. You should bring excellent writing skills, a logical approach to problem solving, and have the ability to operate with minimal direct supervision.
If you are interested in finding out more about this role, or wish to apply, please forward a copy of your CV to David Jolley at email@example.com, or call 07738 586 627. Do you know someone that would be perfect for this job? We pay referral bonuses to anyone that refers a candidate that secures a role through us (Terms and Conditions apply).
Compass Life Sciences is a trading name of Compass Associates Ltd, and are acting as a recruitment agency for this permanent vacancy.