Job Title: Manufacturing Technician
Reports to: Site Manager
Location: Newcastle
Work Schedule: Mon-Fri
Environmental Conditions: Able to lift 40 lbs. without assistance; Adherence to GMP safety standards; Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair; Fluctuating temperatures, loud noises; office and warehouse; PPE required (safety glasses, gowning, gloves, lab coat, ear plugs); Standing for full shift; Strong odors; Hazardous/toxic materials.
Position Summary
Manufacture raw and sterile liquids for use in the pharmaceutical and biotech industry following established protocols and instructions. The products are scientific in nature and this role suits a team member with an interest in science and manufacturing.
Key Responsibilities
* Complete day-to-day production activities in conformance with specifications, standard operating procedures, and cGMP/ISO principles.
* Manage raw processing and sterile/cleanroom operational activities including setup, dispensing, monitoring sampling and testing with limited supervision.
* Manage sterile serum filtration operational activities, including setup, pooling, filtering, and integrity testing.
* Assist with logistical processes for finished goods, semi-finished goods and raw materials including packing, inwards goods receipt, loading and unloading freight.
* Completion of Batch Manufacturing Records (BMR's), ensuring that all information is timely, accurate, legible and correct to guarantee traceability.
* Communicate production issues and potential solutions to Production Supervisor and/or Team Leader as they arise.
* Balance multiple tasks and prioritize critical tasks.
* Use experience and logic to solve moderate to complex problems within process guidelines and assist others to do the same.
* Participate in EHS system by adhering to policies and procedures and reporting hazards to ensure a safe and healthy workplace environment.
* Contribute to the revision of manufacturing documentation including batch manufacturing records (BMR's) and standard operating procedures (SOP's).
* Perform other related duties as required and/or assigned to contribute to the efficient operation of the team and business.
Working Conditions
Working in a controlled, cleanroom environment and warehouse. Required to lift up to 20kg. May be required to stand for long periods of time while performing duties. Must be able to work safely with chemicals and hazardous materials. Must be able to work overtime and be flexible around hours of work, including working Tuesday to Saturday shifts as required.
Minimum Requirements & Qualifications
* Experience in cGMP manufacturing and/or analytical laboratories is preferred.
* Science related qualification is desirable.
* Good mechanical aptitude.
Skills
* Interpersonal skills – Relates openly, comfortably and professionally with diverse groups of people.
* Teamwork/Cooperation – Builds partnerships and works collaboratively with others to meet shared objectives.
* Embraces process improvement – Utilizes continuous improvement tools to improve processes and solve problems.
* Problem solving/decision making – Seeks appropriate data and utilises available problem solving tools before making decisions.
* Focuses on growth – Works to meet business goals set by management.
Personal Qualities
* Proactive, anticipate needs.
* Motivated to get the job done and motivates others.
* Takes ownership.
* Demonstrates flexibility.
* Ability to multi-task.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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