Chemical Process Operator I-2nd Shift

HIKMA•Cherry Hill, NJ

1d•Onsite

About The Position

The Chemical Process Operator I performs weighing, mixing, cleaning, tank movement, and preventive maintenance activities in a cGMP production environment. The role operates under supervision and has no supervisory responsibilities, though demonstrated leadership ability or readiness to assume higher-level responsibilities is preferred. The operator follows formulation procedures to prepare bulk solutions and is expected to work overtime on short notice when production requires.

Requirements

High school diploma and the applicable minimum experience: one year working in a cGMP facility, one year of pharmaceutical liquid batching experience, two years of other batching experience, or two years of practical laboratory experience with an associate or bachelor's degree.
Good oral and written communication skills.
Ability to document process issues clearly and concisely in accordance with cGMPs and SOPs.
Ability to perform arithmetic using whole numbers, common fractions, and decimals.
Ability to understand and follow written, oral, or diagrammed instructions and complex formulation procedures.
Ability to solve problems involving several concrete variables in standardized situations and recommend corrective action.
Ability to comprehend and follow applicable SOPs.
Ability to move and weigh heavy containers up to 100 pounds; lift 45–50 pounds for 25–50% of the time.
For movement of portable tanks, ability to use a power pusher and meet the stated 20/40 distance-vision and hearing requirements (pass a whisper test or have no worse than 40 dBA in the better ear).
Ability to stand for long periods, climb ladders and platforms to dispense chemicals, and wear required personal protective equipment.
Ability to work with raw materials requiring special handling and protective equipment; operators are exposed to raw materials 80% of the time.
Ability to wear a company-issued frock (long laboratory coat), hood, and boots in compounding suites; wear PAPRs and successfully complete and pass pulmonary function testing.
Ability to work in a moderate-to-loud noise environment in CIP washrooms, where hearing protection may be required.

Nice To Haves

Associate degree in science or equivalent.
Ability to assume higher-level responsibilities or demonstrated leadership abilities.

Responsibilities

Maintain regular and predictable onsite attendance and punctuality.
Set up and operate scales, mixers, pumps, CIP units, tanks, and material-handling equipment.
Maintain accurate log books, raw material inventories, reconciliations, and batch records.
Move raw materials as needed for mixing, weighing, and storage.
Weigh chemicals to prepare cleaning-solution batches and, on a limited basis, designated production batches.
Perform acid/base pH adjustments as required by the batch or as instructed by the QA Lab.
Transfer finished batches to specified areas for further processing.
Follow cGMPs and SOPs to ensure product quality and integrity.
Clean equipment and rooms as necessary.
Collect samples and perform other quality checks as necessary.
Perform preventive maintenance on compounding equipment, including tanks, mixers, and pumps, as required or instructed by a supervisor or designee.
Refer process issues to a supervisor or designee and report maintenance or safety issues.
Under supervision, weigh specified quantities and follow formulation procedures to prepare bulk solutions.
Work overtime on short notice when production requires.
Perform other duties as assigned by management.