Process Operator I

Title: Process Operator I
Location: Malvern, PA 19355
Duration: 6 Months

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

MUST HAVES - LIFT 40 + LBS, ABLE TO WEAR AIR SUIT, SOME GMP PREFERRED, DEPENDABLE, BASIC MATH SKILLS.

Job description:

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

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

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:

• 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