Production Operator (Pharmaceutical Manufacturing)

Huvepharma is seeking Production Operators for its regulated pharmaceutical manufacturing facility in Saint Louis, MO. This is an exciting time due to our growth and continued success and we have several openings available. Current schedules are either 1st shift (7am - 5.30pm) Monday - Thursday, or 3rd shift (9pm - 7.30am, Monday - Thursday). Some Friday - Sunday overtime hours can be required throughout the year and dependent on business needs. Pay based on experience and position responsibilities.

We are looking for those with at least 1-2 years production-based operator experience, and strongly prefer candidates who have machine / process operator experience from a batching, filling, CGMP, and packaging operation. Any experience working in a regulated (example FDA) environment or equivalent is highly desired.

In order to be considered, you must have at least a high school diploma or equivalent (GED). 

Technical skills and abilities

• Execute operations in both process batching and packaging on one complete line. This will include passing skill assessment on all process batching and packaging equipment
• Demonstrate the skill to be performer and a verifier on executable batch records
• Execute a batch record without error and pass skill assessment on batch record review during and after completion of a production run
• Demonstrate the ability to train other employees
• Become certified as a performer on unloading bulk trucks
• Operate, clean and troubleshoot blending, packaging or pouching equipment
• Ability to use pallet jacks or operate forklifts
• Stage / weigh raw materials, packaging components or pouching components allocated to specific lots or units
• Read and understand instructions in production documents (records or forms) or protocols
• Accurately document the completion or verification or production steps in batch records or protocols and equipment area logbooks
• Strong communication skills with team and supervision
• Ability to accomplish multiple tasks as required by supervision (blending, packaging, pouching, cleaning, inspections and others)
• Ability to perform simple math calculations (addition, subtraction, multiplications and division of numbers)
• Conscious of safety and quality regulations (use of PPE as required)
• Attention to detail and work with little oversight
• Ability to support cleaning and process validation activities (blending, primary packaging or pouching or validation lots)

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk and listen. The employee frequently is required to stand for long periods. Associates will walk, use hands, handle, feel, and reach with hands and arms. The employee is occasionally required to sit, climb or balance, stoop, kneel, crouch, or crawl. The employee must be able to occasionally lift and or move up to 75 pounds. Specific vision abilities required by this job include peripheral vision, depth perception, color identification and visual acuity.

Position responsibilities

• Operate packaging equipment, materials handling equipment, and monitor downstream equipment for effective operation
• Perform the work assigned on a daily basis in accordance with the Unit Leader or Production Supervisor instructions and batch record requirements
• Report all deviations from batch record requirements, SOPs or company policy, or equipment failure immediately to Unit Leader or Production Supervisor
• Advise Unit Leader or Production Supervisor of needed repairs
• Accurately complete information required on batch record as the job is being done
• Clean unit in accordance with SOPs. Ensure the packaging area is monitored between batches to eliminate any possibility of components or supplies remaining in the work area from preceding batches
• Follow all safety (HSE) requirements. Responsible for adherence to OSHA and GMP
• Perform quality checks during and between each production batch, such as scale checks, verification of lot number and expiry information and proper net weights of bags
• Assure samples are taken properly following SOPs
• Unload bulk shipments in accordance with company SOPs, including appropriate sampling. Unload only after released by Quality Control
• Additional responsibilities as assigned by Unit Leader or Production Supervisor
• Work in controlled and uncontrolled temperature environments

Competencies

• Accountability
• Integrity
• Customer focus
• Adaptability
• Initiative
• Quality orientation
• Teamwork
• Safety awareness

How to apply

Using the form below, please send us your cover letter and CV in English, ensuring that your CV contains only information relevant to your academic and professional background. Please avoid sharing other sensitive personal data. Your application package will be treated with strict confidentiality. The personal data you provide will be treated in the strictest confidence in accordance with the applicable personal data protection legislation. Only shortlisted applicants will be contacted with information about the next steps of our selection process.