Process Technician Senior Coordinator (12 Month Fixed Term Contract)

The Process Technician Senior Coordinator is responsible for all manufacturing and packaging processes with Botanical Drug Product (BDP) using a series of well-defined and documented manufacturing procedures whilst being in compliance with Health and Safety (H&S) and current Good Manufacturing Practices (cGMP) requirements.

Where appropriate, this role will also include direct people management responsibilities including individual/team performance management.

Essential Functions/Responsibilities

Quality is a primary focus to ensure all aspects of cGMP are met and product quality is not compromised. The workload is varied with the core areas of responsibility listed below:

• The job holder is responsible for maintaining cGxP and EH&S knowledge applicable to the job.
• Ensure delivery against schedule, for all BDP production batches.
• Ensure all BDP batch documentation have been processed in accordance with cGMP and current procedures.
• To perform a leading and proactive role within the production areas to ensure procedures are followed correctly and tasks completed in a timely manner.
• Perform routine micro testing in the Commercial Manufacturing Suite (CMS).
• Liaising with other departments on BDP production scheduling, including supply chain, warehouse, engineering, QC and QA.
• Training of other technicians on new processes/changes to manufacturing techniques.
• Identifying areas for improvement and implementing these improvements where applicable across all BDP production processes/working practices.
• Completing additional tasks assigned by production management that are outside the core duties described above.

Required Knowledge, Skills, and Abilities

• Carries out their work in a way that will not adversely affect their own, or others, health, safety and security or the environment and reports any shortcomings in company arrangements.
• Responsible for all manufacturing and packaging processes with BDP in accordance with cGMP standards, both as an initiator and checker.
• Recording of manufacturing/process conditions in batch documentation and equipment/area logbooks.
• Complete area/equipment cleaning procedures to high standards as illustrated in cGMP practices.
• The job holder may be called upon to provide cover for other internal departments, when the BDP production schedule allows.
• Ensures that all activities undertaken comply with cGMP and EH&S standards as detailed in relevant SOP’s and working practices.
• Authors and updates batch documentation, standard operating procedures and associated forms.
• Responsible for the completion of quality related documentation, such as deviations, CAPA’s, protocols and change controls.
• The nature of the work requires the job holder to be flexible, with regards to working hours to ensure that they are available to complete a production process should it overrun.
• Trains and coaches new starters (re-train individuals) in BDP manufacturing and packaging processes.
• Looks for areas of improvement across all BDP manufacturing and packaging processes, in order to improve efficiency and reduce costs.
• Informs department management of any atypical events/deviations immediately.
• Executes additional tasks in order to meet department objectives.
• Potential to act as the BDP department EH&S representative and undertake all of the tasks associated with that role.
• Potential to take responsibility for consumable and critical to quality ordering within the department.
• Ensures that activities under their control are carried out in ways to minimise risks to health, safety, security and the environment.

Required/Preferred Education and Licenses

• Minimum of 3 years experience gained in a regulated production environment, ideally within the pharmaceutical/chemical or food industry.
• Ideally hold qualifications gained in the Pharmaceutical industry i.e. NVQ’s or similar
• Proven experience of team supervision or leadership in Pharmaceutical or related industry
• Displays the attributes encompassed in the company values and encourages their development in others.
• Good level of numeracy.
• Good communication skills including written.
• A good working knowledge of standard Microsoft packages, i.e. Excel and Word.
• Excellent attention to detail.
• Develops and maintains positive working relationships with key stakeholder groups, both internal and external.
• Prepared to challenge the norm and look for areas of improvement, share own ideas and information.
• Good team worker assists colleagues as and when required.
• Demonstrates a ‘can do’ attitude.