Pharmaceuticals Manufacturing Operator Job at Ingenus in Fairfield

Ingenus Pharmaceuticals offers a generous Paid Time Off policy, as well as, 14 paid holidays per year. Medical, Dental and Vision benefits are offered to all associates and are effective on the 1st day of the following month after hire. Enrollment in 401k after 90 days.

The Manufacturing Operator/Technician II is responsible for all functions relating to the processing of drug products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards.

Major Areas of Responsibility
 Execute Batch Record and logbook documentation with clear details and accuracy.
 Execute the procedures used to clean pharmaceutical production equipment and facilities.
 Operates pharmaceutical production machinery and executes procedures for manufacturing such as dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing etc.,
 Executes total changeovers and cleaning.
 Identifies and assists in the corrective actions of processing related issues.
 Maintains production reporting for assigned work unit operation.
 Performs required in-process product quality checks and document accurately.
 Execute procedures to complete tasks in a safe, compliant and efficient manner.
 Works in collaboration with others as part of a team.
 Assists with on the job training of other production trainees and operators.
 May determine methods and procedures on new assignments and may provide assistance to other support personnel.
 Effectively communicates issues to supervisor.
 Adheres to all cGMPs, compliance/regulatory mandates and quality requirements.
 Assists in the identification and implementation of continuous improvement opportunities.
 Performs other related duties as assigned to meet departmental and Company objectives. Required Knowledge, Skills and Abilities
 Knowledge of Metric and English weighing and measurements systems.
 Basic understanding of mechanical machinery and the operating principles of control systems.
 Demonstrated mathematical ability in addition, subtraction, multiplication, division, ratios and percentages.
 Ability to use a calculator.
 Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation.
 Accurate and precise in recording data and batch information.
 Ability to work in both independent and team environments.
 Proficient in reading and writing English to understand work instructions and document results.
 Ability to operate pharmaceutical processing equipment.
 Ability to meet required standards of cGMPs.
 Demonstrated understanding of the unit operations and the ability to assist with on-the-job training of manufacturing trainees and operators.

Education and Experience
 High school diploma or general education diploma (GED).
 Two years’ related experience or equivalent technical training/certification preferred; or a combination of related experience and technical training/certification. Physical Demands
The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job:
 Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear without any aids.
 Capable of lifting or carrying and walk with a minimum of 30 kg alone without any support or aid and higher weights with support or aid as required.
 Capable of moving the machines, filled containers, and other accessories alone or with support or aid as required.
 Work different operational shifts from time to time as required.
 Weekends / holidays and extended hours as required.
 Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
 Operate trucks and other industrial vehicles to transfer the containers/production equipment.
 Manufacturing operator/technician II are expected to operate any industrial machinery such as Forklifts, Hi-Lo, Reach Truck, Hand truck, Pallet Jack, Drum lifter etc. to lift, carry, push, pull or otherwise move objects. Work Environment
The work environment characteristics described here are representative of those an individual encounter while performing the essential functions of this job:
 Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
 Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
 Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
 Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face (Dust / Mist Respirator & Half-Face Air Purifying Respirator) and full-face negative pressure respirators
 Individual may be required to wear hearing protection under certain conditions
 Any employee required to use any type of Air Purifying Respirator must not have facial hair and must be cleanly shaven to assure a proper seal.

Ingenus Pharmaceuticals LLC. is an Equal Employment Opportunity (EEO) employer and welcomes all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, sex, color, religion, national origin, age, disability, veteran status, genetic data, or religion or other legally protected status.