Process Operator

HireTalent; Malvern (Chester County); On-site; USD 35,000 - 50,000; Full time

Job summary

A leading company in Malvern is seeking a Process Operator for a 6-month contract. The successful candidate will be responsible for operating equipment, ensuring adherence to safety and cGMP standards, and maintaining thorough documentation. This role requires physical strength and a high school diploma. Candidates with prior manufacturing experience will be preferred.

Qualifications

• Dependable, eager to learn, physical requirements able.
• Prior manufacturing experience preferred.
• Ability to work overtime on weekdays and weekends.

Responsibilities

• Perform entry-level micronization and milling of pharmaceutical actives.
• Operate equipment and monitor production processes.
• Document production following good documentation procedures.

Skills

Communication Skills Oral and Written

Basic Math Skills

Education

High School Diploma or GED

Tools

Personal Protective Equipment

Job description

Job Title: Process Operator
Job Location: Malvern, PA
Job Duration: 6 months on W2
Shift: 1PM - 11:30PM
May Start Training on 1ST Shift

Description:
The Process Operator micronize\mills client provided material including both active pharmaceutical
ingredients and excipients as per *** Malvern procedures and policies, client instructions
and cGMP guidelines. Consistently models *** values and leadership behaviors in all interactions.

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.
• This is a site-based position.
• Strive to achieve First Time Right (FTR) as a key performance indicator (KPI) in order to meet our yearly targets.
• Remain current with Compliance Wire and other site training.
• Perform all other duties assigned by management

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

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 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.
• 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