To safely manufacture chemical products involving the ability to follow and comply with defined procedures/regulatory requirements, assemble and operate automated/semi-automated equipment while following defined safety policies.
MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
* Perform manufacturing and assembly of products in accordance to written production records while observing appropriate safety guidelines.
* Operate semi-automated and automated manufacturing equipment.
* Weigh, measure, blend and check solid, chemical or liquid raw materials to assure batches manufactured contain proper materials and quantities.
* Maintain proper production records to comply with ISO requirements, SOPs and Work Instructions.
* Properly operate chemical charging system and glass-lined reactor, including the cleaning and maintenance of equipment.
* Perform liquid transfer between tanks using diaphragm pumps.
* Properly operate plant equipment, which may include but is not limited to the following: chillers, reactors, pH systems, centrifuges, crystallizers, dryers, boilers, etc.; also responsible for daily cleaning and maintenance of equipment.
* Maintain equipment and rooms in proper operation condition by following daily cleaning requirements.
* Perform activities in controlled environment, while assuring the use of appropriate PPE equipment.
* Perform in-process testing to assure batches meet specifications.
* Performs other duties as assigned.
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)
* Frequently exposed to moving mechanical parts, fumes, airborne particles, dust or gases. The employee is occasionally exposed to toxic or caustic chemicals. The noise level in the work environment is usually moderate.
* Required to stand and walk for a large part of the working day. Physical requirements include talking, hearing, bending/stooping, squatting, reaching above shoulder height, crouching, kneeling, balancing and pushing/pulling. Also requires some lifting/carrying/pushing or pulling up to 50 pounds with or without assistance. Use of both hands for repetitive actions such as grasping and manipulating. Specific vision abilities include close vision, peripheral vision, depth perception, and ability to adjust focus.
QUALIFICATIONS (Education/Training, Experience and Certifications)
* High school diploma required; Associates degree in a life science or engineering discipline preferred
* 1-3 years prior experience in a cGMP manufacturing environment, along with general understanding of semi-automated and/or automated equipment is preferred
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
* Knowledge of computer applications is desirable
* Ability to evaluate internal customer needs, and respond with appropriate action/delivery