Machine Operator

Title:: Machine Operator I

Location: Malvern, PA 19355

SHIFT - MON-THURS 1PM - 11:30PM

Summary:

The Process Operator micronize\mills client provided material including both active pharmaceutical ingredients and excipients as per the client Malvern procedures and policies, client instructions and cGMP guidelines. Consistently models the client 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 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.

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 tthe 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
• 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 tbe 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 t44 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