What are the responsibilities and job description for the Bulk Mfg Tech II position at FAREVA?
Job Details
Description
Bulk Manufacturing Tech Levels I - III
Fareva is currently seeking an experienced Bulk Manufacturer Levels I - III to join the team for 3rd shift, in Richmond, VA.
Job Description This position requires a minimum of 1 years of experience. You will be responsible for all aspects of bulk solution preparation and equipment use. All work is done following cGMPs, PPGs, and safety requirements. Under the direction of a Facilitator and/or Group Leader, the Bulk Manufacturer Level I - III will prepare bulk solution to be packaged. Visually inspects products for defects or other quality problems and initiates corrective action when necessary. Controls and accounts for all raw material used. Work is determined by the production schedule and is assigned by the Production Facilitator/designee. Work is directed by production batch records, equipment cleaning records, and PPG's/JA's. Upon completion of the work it is delivered to the department's customers.
Job Responsibilities:
- Orientation to all equipment used including set-up, operation, troubleshooting & shutdown.
- Instructions in all aspects of the operation; PPG's, batch record & documentation requirements, proper formulations and sampling techniques.
- Weighs specified quantities and follows formulation procedures in the preparation of bulk solution.
- Handle all raw materials to prepare batches.
- Sets up and operates equipment used in compounding, i.e. mixing equipment, filtering equipment, compounding tanks and pumps, chart recorders on a daily basis.
- Sets up and utilizes scales on a daily basis.
- Moves raw material as required for compounding, weighing or storage with hand trucks and forklifts as required.
- Performs pre-filtration of bulk solutions.
- Coordinates the transfer of finished batches to specified tanks or areas for further processing
- Maintains accurate records, i.e., logbooks, raw material inventories, reconciliations and batch production records, checks Production Batch Records for accuracy, and operates MES Enterprise computer system
- Navigates SCADA dispensing system to dispense bulk raw materials
- Completes all documentation clearly and legibly
- Performs tank rinsing, cleaning and sanitation procedures, and all other duties as assigned by supervisor
- Adheres strictly to all cGMPs, PPGs, and safety procedures to ensure the quality and integrity of products and safety of employees.
- Reports all accidents, incidents and near misses to supervision immediately
- Ability to perform mathematical calculations, i.e., conversions volume to weight, English to metric, yields, specific gravity
- Keeps working area in a clean and orderly condition according to PPG's and 5S principles
- Actively participates in team activities including continuous improvement efforts, cost reduction initiatives and process improvements.
Requirements Education and Experience:
- High School diploma or equivalent
- Ability to obtain forklift certification within 6 months
- Qualified candidates should be flexible to work shifts 1st, 2nd or 3rd
Abilities and Skills:
- Must be able to read, demonstrate math ability and understanding
- Comprehend and follow written and oral instructions
- Ability to visually verify steps in process
- Possess good eye/hand coordination
- Must be able to pass (Fareva's basic computer navigation skills assessment.)
- Movement and weighing of heavy containers from 50 - 100 lbs. with appropriate equipment.
- Must be able to lift up to 50 lbs.
- Work may involve exposure to raw materials such as pharmaceutical active ingredients (PAI's), which may require the use of personal protective equipment (gloves, aprons, safety shoes, goggles, face shield or respirators), exposure to high temperature water and steam and wet floors, handling of flammable liquids, caustic solutions and compounds.
- Will work with the following tools/equipment: mixing equipment, filtering equipment, compounding tanks, pumps, scales and any other equipment necessary to accomplish the task.
- Employees working in Bulk Manufacturing are required to wear respirators for some job tasks. In order to protect employee health and safety, the use of respirators are required when working with certain chemicals in compliance to the OSHA Respiratory Standard. Employees are required to follow all of the requirements for the Respiratory Program.
What we offer:
Competitive salaries, comprehensive health/vision/dental insurance, company paid short term disability, company paid life and accidental death insurance, 401(k) plan match of 4.5% with immediate vesting, generous employee referral program, paid vacation annually, paid holidays annually, onsite cafeteria, job advancement opportunities. Manufacturing employees also receive company paid work shoes, uniforms and prescription safety eyeglasses. Second & third shift employees receive a 10% shift differential.
Qualifications