Technical Operator Bulk
Technical Operator Bulk
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Job Description
Work Schedule
OtherEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Loud Noises (Equipment/Machinery) Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.) Will work with hazardous/toxic materialsJob Description
Working shifts: 24/7 rotating between day and night shifts
Location/Division Specific Information:
Thermo Fishers Swindon facility is part of the Drug Products Division which specialises in taking sterile injectable oral solid dose and softgel drug products from development to commercialisation.
How Will You Make an Impact:
Within your role as a Technical Operator youll do meaningful work and work closely with a team that values performance quality and innovation.
Responsibilities:
- Preparation testing and set up of multiple modules in readiness for manufacturing and fill/finish processes CIPs. SIPs Filter Integrity testing Pressure Tests Autoclaving Decontamination by VHP and cleanroom cleaning.
- Establish and run small and large-scale compounding systems as per SOPs.
- Formulation of Pharmaceuticals applying tailored manufacturing skids vessel systems in compliance to batch manufacturing records.
- Perform Manufacturing operational duties e.g. complete batch & associated documentation right first time for accordance with SOPs to ensure compliance with cGMP.
- Set equipment to ensure minimum downtime levels minimum product damage/waste support machine start-up changeovers testing and cleaning activities in accordance with SOPs and cGMP requirements.
- Monitoring equipment status and readiness for production reporting any faults or issues to Supervision
- Cleaning and maintenance of area/equipment to SOPs cGMP and pharmaceutical industry regulatory standards.
- Perform Clean In Place (CIP) and Steam In Place (SIP) activities using HMI controlled systems.
- Operating airlocks autoclaves and automated vessels/equipment cleaning systems for the purpose of ensuring that all equipment is sterilized and ready for use.
- To ensure any instances of non-conformance are communicated to the area leader Manager or Quality Assurance representatives to ensure that they are investigated and rectified.
- Support project validation work new product introduction to the Operations department
- SAP transactions.
- Using Quality systems for GMP changes and report writing.
- Assist Engineering where appropriate in basic equipment maintenance.
- Conduct environmental monitoring in accordance to procedures.
Education:High School Diploma Secondary Education Advanced Certificate or equivalent.
Experience:
- Required: Minimum of 1 year of work experience in a manufacturing operations production lab setting or related field
- Preferred: Experience in a cGMP environment
Knowledge Skills Abilities:
- Ability to follow verbal and written instructions and production schedules.
- Ability to remain focussed and have attention to detail.
At Thermo Fisher Scientific each one of our 100000 extraordinary minds has a unique story to tell. Join us and contribute to our outstanding missionenabling our customers to make the world healthier cleaner and safer.
Employment Type
Full-Time
