Description / Comment :

ONSITE - TEMP TO HIRE - SHIFT - MON-THURS 1PM - 11 : 30PM

The Process Operator micronize mills client provided material including both active pharmaceutical

ingredients and excipients as per Catalent Micron Technologies procedures and policies, client instructions

and cGMP guidelines. Consistently models Catalent values and leadership behaviors in all interactions.

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

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 Client 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.

Start Time : 12 : 00 AM

12 : 00 AM

Hours : 8 : 00am to 5 : 00pm

8 : 00am to 5 : 00pm

Location :

117 333 Phoenixville Pike 23-2851924 Malvern PA 19355 United States

Education :

Additional Job Details :

Last updated : 2024-06-24