PURPOSE & SCOPE OF THE POSITION
The Manufacturing Technician contributes to developing Symbiosis’ mutually beneficial relationships by:
- Processing and manufacturing of aseptic products, from the ordering of raw materials to the dispatch of the finished pharmaceutical product for clinical trial use.
- Manufacturing of aseptic products, including maintaining the status of a validated aseptic clean room operator, material preparation, reconciliation, labelling and packaging.
- Educated to a minimum of 5 National 5’s or Higher in Mathematics and English.
- Educated to degree level in Life Sciences.
- Ability to follow and complete manufacturing documentation accurately.
- Experience of a GMP controlled cleanroom environment.
- Knowledge of pharmaceutical manufacture.
- Lean manufacturing experience.
- Effective communication skills.
- Flexible and adaptive team player.
- Ability to perform multiple tasks effectively in a busy environment
Working hours for this role are 2-week shift pattern.
- Week 1: 7am – 3pm
- Week 2: 2pm to 10pm.
If you would like to apply for this role, please send your CV and cover letter, detailing your salary requirements to firstname.lastname@example.org
- Complete all batch manufacturing records and all associated documentation to cGMP and SOPs.in an accurate and timely manner.
- Undertake general house-keeping and maintenance of the facility in an audit-ready’ state at all times.
- Participate in training sessions.
- Participate in the continued improvement of systems within the facility to ensure efficient and timely manufacturing process.
- Perceive problems as they develop and communicate such to the Manufacturing Team Leader.
- Ensure training records are up to date and accurate as per current SOP revisions
- Ensure cleanrooms are cleaned as per procedures and timelines
- Prepare components and consumables for use in manufacturing.
- Set up the cleanroom and equipment in preparation for manufacturing.
- Ensure correct materials are processes as per BMR’s.
- Undertake routine in-use monitoring of cleanroom suites during manufacturing.
- Prepare and filter bulk drug solutions, including undertaking filter integrity tests as part of the manufacturing process.
- Fill, stopper, and crimp liquid and lyophilised drug product.
- Reconcile all materials used in the manufacturing process
- Reconcile finished product materials.
- Undertake sampling of finished product
- Package and label all finished products
Compliance & Quality Management
- Maintain a clean and safe workplace in accordance with GMP and Health & Safety guidance.
- Assist in the undertaking of reviews associated with Corrective Action/Preventative Action (CAPA), deviations (including investigations and out of specifications).
- Support validation and qualification of equipment and processes as required.
Management & Development of Team
- Assist the Manufacturing Management Team in the induction of manufacturing staff to ensure they are clear about how they contribute to Symbiosis and can operate at their best.
- Understand the other team members’ needs, capabilities and preferred ways of working, and provide them with support and feedback.
- Attend, participate and contribute to regular staff and management meetings, as necessary.
- Invest in developing relationships with all staff to fully understand the needs of other staff and communicate accordingly.
- Invest in developing relationships with the management team to ensure we are a high performing Manufacturing team and Symbiosis’ services meet expectations.
- Act as an ambassador for the company.