Pharmaceutical API Technician I

Skilled Pharmaceutical API Technician I (Manufacturing Operator)

• 1st shift timings - 6:00 am to 2:30 pm
• 2nd shift timings - 2:00 pm to 10:30 pm

SUMMARY
Performs all functions relating to the processing of drug substances (also known as Active Pharmaceutical Ingredients (API)); consistent with established Current Good Manufacturing Practices (cGMP), Batch Records and SOPs. Responsible for the safe and efficient execution of the job duties, while ensuring product compliance to established standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Operates pharmaceutical production machinery, handles chemicals (acids, bases, corrrosive & toxic chemicals) and executes procedures for manufacturing such as dispensing, mixing, reaction, centrifuge, distillation, purification, drying and the like after receiving training. Complete training qualification to operate independently.
• Executes Batch Record and logbook documentation with detail, as steps are completed and with accuracy.
• Executes the procedures used to operate and clean pharmaceutical production equipment and facilities.
• Executes changeovers and line clearances, ensuring equipment and facilities are free of product and any contamination.
• Maintains production reporting for assigned work unit operation.
• Performs required in-process product quality checks and documents accurately.
• Executes procedures to complete tasks in a safe, quality-minded and efficient manner.
• Works with integrity, transparency and in collaboration with others as part of a team.
• Effectively communicates issues to supervisor and always maintains integrity and transparency.
• Adheres to all cGMPs, compliance/regulatory mandates, quality and safety requirements.
• Assists in the identification and implementation of continuous improvement opportunities.
• Performs other related duties as assigned to meet departmental and Company objectives.

Qualifications

Must be capable of working various hours/shifts, and weekends when necessary. A strong background in Pharmaceutical API manufacturing or education in STEM is a plus.

KNOWLEDGE/SKILLS/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.
• Demonstrated ability to work in both independent and team environments.
• Proficient in reading and writing English to understand work instructions and document results.
• Demonstrated ability to operate pharmaceutical processing equipment.
• Demonstrated 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/EXPERIENCE

• Student pursuing Undergraduate degree in STEM preferred.
• High school diploma or general education diploma (GED) with two years’ related experience or equivalent technical training/certification preferred; or a combination of related experience and technical training/certification.

Additional Information

WORK ENVIRONMENT
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:
1. Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.
2. 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.
3. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:
1. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
2. Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
3. Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
4. Individual are required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

All your information will be kept confidential according to EEO guidelines.

Job Type: Full-time

Pay: $20.00 - $21.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Maryland Heights, MO 63043: Reliably commute or planning to relocate before starting work (Required)

Experience:

• cGMP: 1 year (Required)

Work Location: In person

Salary : $20 - $21