Process Operator in Malvern

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Job DescriptionJob Description

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

START TRAINING ON 1ST SHIFT FOR A COUPLE OF MONTHS 6:00AM – 2:30PM MON-FRI ONCE THEY MOVE OVER TO 2ND SHIFT AFTER TRAINING - MON-THURS 1PM - 11:30PM.

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

• 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.

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 .
• 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

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 novel compounds of unknown potency and toxicity

Company DescriptionAbout company - Since its founded in 1996, CTC has grown into a trusted global partner in AI & ML, Enterprise Applications, Digital Services, Managed Services, and Business Services. With headquarters in Detroit, Michigan, CTC has a team of over 2,000 experts worldwide. We empower more than 100 organizations to tackle complex challenges and transform them into sustainable competitive strengths--driving innovation, efficiency, and growth every step of the way. Our strengths have always been Commitment to Customer, Commitment to Colleagues, and Commitment to Community (CTC).Company DescriptionAbout company - Since its founded in 1996, CTC has grown into a trusted global partner in AI & ML, Enterprise Applications, Digital Services, Managed Services, and Business Services. With headquarters in Detroit, Michigan, CTC has a team of over 2,000 experts worldwide. We empower more than 100 organizations to tackle complex challenges and transform them into sustainable competitive strengths--driving innovation, efficiency, and growth every step of the way. Our strengths have always been Commitment to Customer, Commitment to Colleagues, and Commitment to Community (CTC).

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