Chemical Machine Operator - Pharmaceutical GMP

Pharma Resource Group; Malvern (Chester County); On-site; USD 35,000 - 45,000; Full time

Benefits offered by this job

$500 sign-on bonus

Training provided

Personal protective equipment provided

Job summary

A pharmaceutical processing company is seeking a Process Operator in Malvern, PA. The role involves micronizing client materials, adhering to GMP standards, and maintaining documentation. Ideal candidates have a high school diploma, strong math skills, and the ability to lift 44 lbs. This full-time position includes a training shift and requires dependability and physical strength.

Qualifications

• Must be dependable and ready to learn.
• Prior manufacturing experience preferred.
• Ability to meet physical job requirements.

Responsibilities

• Micronize pharmaceuticals as per client procedures.
• Set up and operate equipment.
• Monitor production processes according to GMP standards.

Skills

Basic math skills

Communication Skills (Oral and Written)

Education

High School Diploma or GED

Job description

Shift: MON-THURS 1PM - 11:30PM. Start training on 1st shift. Must-haves: lift 40+ lbs, able to wear air suit, some GMP preferred, dependable, basic math skills. $500 sign-on bonus before converting to full-time after 6 months.

The Process Operator micronizes client-provided material, including both active pharmaceutical ingredients and excipients, as per Client's Malvern procedures and policies, client instructions, and cGMP guidelines. Consistently models Client's values and leadership behaviors in all interactions.

Operator I Functions

• 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.

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

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: Communication Skills (Oral and Written), Basic Math Skills, interpretation. Potential limited exposure to health & 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.

Physical Requirements/Work Environment

Physical strength, stamina, and dexterity while wearing a fully enclosed air suite. Employees must 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. 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.