You will responsible for a results-based program of benefit to the site in terms of revenue, cost reduction, increased efficiencies is generated and realised.  This will involve working with all relevant Managers, Department Heads to plan, and implement new operational effectiveness projects within the specific areas, and covering the site.  You will also need to support all relevant Managers, Department Heads in the use of various Continuous Improvement Tools to allow self generating projects to be developed and implemented.

Previous experience in a similar function, or operational experience, is essential for this role.  Experience in Continuous Improvement, or Lean Six Sigma, trained to Green or Black Belt would be an advantage but is not a pre-requisite for the role.

You will need to be disciplined; with the ability to manage and report against a project schedule and drive plan implementation to conclusion.  You will also need strong computer software skills, particularly with data manipulation / spreadsheets.

You will be responsible for supporting the production lines to ensure that they achieve the maximum output, productivity, efficiency and quality throughout all areas of manufacturing and filling operations.  This will include maintaining the quality of the output of equipment at all times during servicing, breakdown or improvement operations.

You will also be required to carry out tasks of first level to support planned preventative maintenance operations, complying with relevant procedures.

Applicants must have previous experience in a similar role, and ideally an engineering qualification.

You will be responsible for providing regulatory support – internally for specified site and product compliance activities, and externally for client regulatory projects and regulatory services such as CTD quality writing (primarily for variations and post-approval changes).

The wide variety of dosage forms developed and manufactured on site will provide you with the opportunity to broaden your regulatory skills within initial applications (NDA/MAA) and through early stage development (IND/IMPD).

You will need previous Regulatory Affairs experience gained in the pharmaceutical or biotechnology industries.  Previous MHRA exposure would be an advantage.  Degree qualified in a scientific discipline, you will be an excellent communicator, both in writing and orally, in order to interface across functions.

You will be responsible for carrying out planned and unplanned engineering work orders in an efficient manner to ensure that the plant and equipment maintain a high level of reliability and availability – ensuring that high standards of safety and quality are maintained during all works at all times.

You should have a mechanical electrical apprenticeship and/or NVQ level 3 or equivalent.

You must have demonstrable expertise of working within a manufacturing and /or regulatory environment.

You will be responsible for the operation of production lines to support the maximisation of output, productivity, efficiency and quality throughout all areas of manufacturing and filling operations.  This will include batch preparation and manufacturing of different products.

You will also be responsible for the set up, changeover and optimisation of machines, as well as conducting initial fault diagnosis in a logical manner – escalating where appropriate.

Previous pharmaceutical production experience is essential for this role.

You will perform routine laboratory procedures and, where relevant, also over-see the work of others within the section.  You will also assist in the planning and prioritising of day to day workload in line with client requirements and adapt this where necessary in line with client needs and expectations.  Your role will also involve you in the review of analytical and laboratory data within the section for accuracy, completeness and compliance with documented procedures.

You will need a degree [or equivalent experience] in Chemistry / Microbiology or a strongly related scientific discipline.  Previous laboratory experience desirable.

You will be responsible for the weekly production plan compliance and driving the line performance to ‘standard’ as a minimum.  This will include the accurate and timely closure of batch documentation, deviation reports and complaints, as well as the daily co-ordination of the allocated staff and activities to meet production schedule and targets.

Previous experience of pharmaceutical production or a similar environment is required for this role.  You will also need demonstrated expertise in leadership, task management, documentation and operations.

You will provide project support to projects as they are identified – including Continuous Improvement projects.  In addition, you will provide proactive definition and implementation of changes to maintenance systems and the performance of equipment.

You must have previous experience of effective planning and implementation of improvement projects, together with a technical school / college based engineering qualification to HNC level.

You achieve in this role you will need to have a dynamic proactive approach to taking on challenging assignments and have the ability to work with critical timelines.

You will be responsible for the generation and execution of validation documentation (SQ/IQ/OQ/PQ) for commissioning of the facility and equipment – ensuring that all documentation is prepared, authorised and completed in a timely manner.

You must have previous experience of working in quality operations/validation of equipment and processes, with an in-depth knowledge and understanding of cGMP.

It’s essential that you’re an excellent planner, who can envision short-term milestones which the company must achieve to succeed in the long-term.