12 Month FTC
We are looking for individuals to carry out day to day operations of a sterile GMP filling facility. We are currently building a new purpose-built facility you will have the opportunity to join at the beginning of the project and be part of the initial set up involved in the validation and qualification of the building and equipment. You will have the opportunity to be cross functional taking part in validation activities and working closely with QA and QC.
Regular onsite presence required to fulfil duties.
- Ensure compliance with all regulatory requirements and maintain excellent GMP, quality control and safety.
- Excellent attention to detail and accuracy, all paperwork to be completed accurately and in a timely manner compliant with cGMP.
- Support the sterile Team Leader at weekly meeting, KPI’s, planning and deviation investigations
- Experienced in working in a sterile environment, an isolator or RABS unit (Grade A).
- Work with single use sterile technologies, and closed systems
- Demonstrate ability to build bonds and work with other departments QA, QC, Validation etc.
- Prepare autoclave and washer loads in accordance to procedure
- Write and review new SOP’s and Batch records and roll these out to the team
- Have the flexibility to operate in all areas of production, sterile operation, validation equipment, cleaning and autoclaving
- On-going cleaning, environmental monitor and building compliance
- Investigate and any deviations and action CAPA’s
- Perform regular cleaning of the cleanroom to ensure it remains within GMP standards.
- Perform stock management tasks within the warehouse
- Knowledge of Six Sigma or Lean manufacturing and implementing continuous improvements
- Minimum of 2 years GMP experience in a production environment with experience of sterile production and demonstrated aseptic techniques.
- At least 2 years’ experience in manufacturing.
- Experienced in Clean Room Grade A environments, Isolators or RABS.
- Should be assessor or qualified in safety systems, i.e. COSHH, risk assessments, manual handling or IOSH Managing Safely.
- Experienced working with Excel and Word.
- Knowledge of lean production or six Sigma.
- Evidence of excellent attention to detail and ability to follow Standard Operating Procedures.
- Experienced in writing SOPs for cleanroom activities.
- Knowledge of validation operations, such as; FATs, SATs and IOQ/PQ.
- Ideally have a degree in a science, or A level equivalent
- Good level of written and spoken English
- Comfortable with a variety of tasks in the supporting role
- High attention to detail
- Ability to work in a team and build working relationships with the QP, Validation, Supply chain and QC Open, honest, inclusive, personable
- A team player with good interpersonal and communication skills
If you are interested in applying for this position, please send a CV and covering letter to firstname.lastname@example.org with the subject line “Sterile Manufacturing Technician”.