Aseptic Manufacturing Technician

Following a decision to expand our services, Spirit Medical Limited is delighted to offer several new opportunities for Aseptic Manufacturing Technicians to join our growing team. This is a chance to be part of a newly established unit dedicated to the aseptic preparation of medicines within a GMP cleanroom environment, where quality and precision are paramount.

As an Aseptic Manufacturing Technician, you will play a vital role in delivering life-enhancing treatments to patients across the UK. Working to the highest standards of safety and quality, your contributions will have a direct and meaningful impact on patient care and outcomes.

We are seeking individuals who are quality minded, able to follow detailed instructions with accuracy, and capable of multitasking effectively in a fast-paced environment. This role is ideal for candidates with previous GMP manufacturing experience, but we also welcome applicants with a suitable scientific background who are eager to learn and develop in a highly regulated setting.

This is a permanent, full-time (37.5 hours) on-site position with working hours set to 08:00-16:00 as standard, although flexibility may be required from time to time subject to agreement.

• Coordinate day to day activities to ensure products are prepared to a high standard and in accordance with the manufacturing schedule.
• Manufacture or support the manufacture of aseptically prepared medicines including the preparation of labels and Batch Manufacturing Records (BMRs), assembly, checking and decontamination of starting materials, carrying out in process checks, and also viewing, labelling, and packing of finished products.
• Working within a grade C/D cleanroom whilst adhering to cleanroom best practice and gowning (PPE) requirements.
• Adhere to local Standard Operating Procedures (SOPs) and ensure consistent compliance with GMP and regulatory requirements.
• Participate in routine and periodic cleaning, disinfection, and environmental monitoring of cleanrooms and isolators.
• Ensure accurate and contemporaneous record keeping across BMRs, logs, forms, and other records. File and archive documents to ensure records are organised and can be easily retrieved.
• Participate in and document all training, validation, and re-accreditation necessary to carry out the role; Once suitably experienced, to assist in the training of other staff.
• Take part in stock management, ordering, and rotation to ensure there are sufficient materials for manufacture whilst keeping waste to a minimum.
• Contribute to routine quality assurance activities, including: Deviation investigations, Change Control implementations, Risk Assessments, Data collection and trending.
• Assist in the execution of equipment qualification and process validation activities to ensure suitability and ongoing compliance.
• Undertake any other duties of a similar nature as required by the Aseptic Services Manager.

• Degree in a relevant scientific discipline or equivalent practical experience.
• Good attention to detail and an understanding of the basic principles of data integrity i.e. ALCOA+.
• Strong organizational and communication skills including a good background of written technical English.
• Manual dexterity / good hand to eye coordination to allow for the aseptic preparation of medicines as well as the ability to handle physical tasks such as mopping cleanroom walls and ceilings, manual handling and sitting or standing for extended periods of time when manufacturing.
• Ability to work as part of a team as well as independently once suitably trained; able to multitask and adapt to changing priorities.
• Computer literate.

• Experience of carrying out activities in a cleanroom environment such as sterile or aseptic manufacture, cleaning and disinfection or environmental monitoring.
• Previous experience working with isolator technology, particularly with hydrogen peroxide gassing isolators.
• Knowledge and understanding of Current Good Manufacturing Practice (cGMP) as well as Good Documentation Practice (GdocP).
• Previous involvement in quality systems, including deviations, change control, and validation processes etc.

Think you’re a good fit? We can’t wait to hear from you! Please submit a copy of your CV before midnight on the date of closing, please note applications may close early if sufficient applications are received.