Process Operator

II. Essential Functions:

• Micronization and milling of both hazardous and non-hazardous pharmaceutical actives and excipients.

• Set up, operate equipment, and monitor production processes and report production on batch records in accordance with good documentation procedures (GDPs)

• Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as required.

• Ability to work in a regulated environment with adherence to standard operating procedures

• Capable of reading and following defined SOPs and policies and executes tasks accordingly.

• Work in accordance with cGMP. Identify and communicate non-routine events, deviations and GMP deficiencies to supervisor in a timely manner.

• Cleaning of the entire processing area and processing equipment.

• Produce thorough, clear & consistence documentation in compliance with Quality Standards (Attributable, Legible, Contemporaneous, Original and Accurate)

• Willingness to accept change, learn, and work with new processes.

• Stops and asks questions or suggests improvements when something is unclear.

• Participate in shift change meetings, site/team meetings, sending/receiving emails, offering suggestions for improvements, and participating in projects.

• Strives for First Time Right

• Remains current with CompliaceWire and other site training

• Carry out all duties in line with the procedures and policies set forth by Catalent Micron

• This is a site-based position.

Measures of Performance:

• Adherence to safety and quality procedures

• Product quality, throughput and final yields

• Excellent attendance, punctuality, and dependability

• Operators’ work ethic and general attitude as it pertains to the daily operations of the facility

III. Position Requirements:

Education or Equivalent:

High School Diploma or GED

Experience:

Must be dependable, ready/eager to learn and able to meet the physical requirements of the job.

Prior manufacturing experience and work in a regulated environment preferred.

Ability to work weekday and weekend OT a plus.

Knowledge/Skills Requirements:

Technical Skills/Knowledge

• Organizational Skills

• Detail Orientation

• Communication Skills Oral and Written

• Basic Math Skills, interpretation

• Ability to Multi-task and prioritize

• Willingness to accept change, learn, and work with new processes.

• Potential limited exposure to heath & physically hazardous chemicals.

• Personal protective equipment, including gloves, a respirator hood, safety glasses, safety shoes and other Personal Protective Equipment is provided and is required to be worn in designated areas.

• Prior Production Experience preferred

Physical Requirements/Work Environment:

• Physical strength, stamina and dexterity while wearing fully enclosed air suite

• Employees be able to lift or move items up to 44 lbs. (20kg) individually, or with a two-person lift between 45 lbs and 76 lbs. (35kg). 77 lbs and over with a lift assistance device.

• Ability to work safely with high potency active pharmaceutical ingredients (HPAPI) as well as novel compounds of unknown potency and toxicity

• Ability to perform moderate physical labor including:

 lifting, climbing, bending,

 crouching, reaching and twisting

• Ability to stand or walk for up to 8 hours per day.

Job Types: Full-time, Contract

Pay: $20.75 - $23.00 per hour

Schedule:

• 10 hour shift
• Evening shift

Education:

• High school or equivalent (Preferred)

Experience:

• Manufacturing: 2 years (Preferred)
• CGMP: 2 years (Preferred)

Ability to Relocate:

• Malvern, PA: Relocate before starting work (Required)

Work Location: On the road

Salary : $21 - $23