Process Operator

Medvacon Life Sciences•Malvern, PA

10d•Onsite

About The Position

The Process Operator micronizes and mills client-provided material including both active pharmaceutical ingredients and excipients as per procedures and policies, client instructions, and cGMP guidelines. The role consistently models values and leadership behaviors in all interactions. This is a site-based position.

Requirements

Must be dependable, ready/eager to learn and able to meet the physical requirements of the job.
Lift 40+ lbs.
Able to wear an air suit.
Basic Math Skills, interpretation.
High School Diploma or GED.
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.
Ability to climb steps/ladders and occasionally work from elevated platforms.
Ability to wear a respirator hood and pass the required respiratory medical exam.
Ability to work in loud environments and wear various types of hearing protection.
Ability to work with chemicals, health/physical hazardous material safely and in compliance with the site safety program.
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.

Nice To Haves

Some GMP preferred.
Prior manufacturing experience and work in a regulated environment preferred.
Ability to work weekday and weekend OT a plus.

Responsibilities

Perform entry-level micronization and milling of both hazardous and non-hazardous pharmaceutical actives and excipients.
Set up, operate equipment, and monitor production processes.
Report production on batch records following good documentation procedures (GDPs).
Work in a regulated environment with adherence to standard operating procedures and policies.
Adhere to cGMP standards.
Identify and communicate non-routine events, deviations, and GMP deficiencies to supervisor promptly.
Clean the entire processing area and processing equipment.
Produce thorough, clear, and consistent documentation in compliance with Quality Standards (Attributable, Legible, Contemporaneous, Original, and Accurate).
Demonstrate willingness to accept change, learn, and work with new processes.
Stop and ask questions or suggest improvements when something is unclear.
Participate in shift change meetings, site/team meetings, sending/receiving emails, offering suggestions for improvements, and participating in projects.
Strive to achieve First Time Right (FTR) as a key performance indicator (KPI) in order to meet our yearly targets.