Job Description

Process Operator I

Job Location: Malvern, PA

Job Duration: 6 Months on W2 (Temp to Hire)

Schedule: Training on 1st Shift Regular Shift: Monday-Thursday, 1:00 PM - 11:30 PM Overtime and weekend work may be required Shift differential available upon full-time conversion

(Note: START TRAINING ON 1ST SHIFT - MUST HAVES - LIFT 40 + LBS, ABLE TO WEAR AIR SUIT, SOME GMP PREFERRED, DEPENDABLE, BASIC MATH SKILLS. $3 SHIFT DIFF AFTER THEY CONVERT TO FULLTIME.)

Position Overview

The Process Operator I is responsible for performing entry-level micronization and milling operations of pharmaceutical materials, including active pharmaceutical ingredients (APIs) and excipients, in accordance with customer requirements, cGMP regulations, and company procedures. This role supports manufacturing operations by operating production equipment, maintaining accurate documentation, ensuring product quality, and adhering to strict safety and compliance standards.

Key Responsibilities:

• Perform micronization and milling of hazardous and non-hazardous pharmaceutical materials
• Set up, operate, monitor, and clean processing equipment and manufacturing areas
• Complete batch records and production documentation following Good Documentation Practices (GDP)
• Adhere to cGMP requirements, SOPs, and quality standards
• Identify and report deviations, non-routine events, and safety concerns to management
• Participate in shift handoffs, team meetings, training, and continuous improvement initiatives
• Maintain accurate, complete, and compliant production records
• Support First Time Right (FTR) and operational excellence goals
• Follow all safety procedures and properly utilize required PPE

Required Qualifications:

• High School Diploma or GED
• Strong attendance, reliability, and willingness to learn
• Basic math and communication skills
• Ability to follow detailed procedures and work in a regulated environment
• Prior manufacturing, production, or GMP experience preferred
• Experience working in pharmaceutical or regulated industries is a plus

Physical Requirements:

• Ability to lift and move up to 44 lbs independently and heavier loads with assistance as required
• Ability to wear a fully enclosed air suit, respirator hood, and other required PPE
• Ability to stand, walk, bend, crouch, climb, reach, and perform physical tasks throughout the shift
• Ability to work in loud manufacturing environments and wear hearing protection
• Ability to safely handle pharmaceutical materials and potentially hazardous chemicals
• Ability to work on ladders, stairs, and elevated platforms when necessary

Preferred Qualifications:

• GMP or pharmaceutical manufacturing experience
• Production or process operation experience in a regulated environment
• Flexibility to work overtime and weekends as needed

Key Success Factors:

• Commitment to safety, quality, and compliance
• Strong work ethic, dependability, and punctuality
• Attention to detail and accurate documentation practices
• Ability to work effectively in a team-oriented manufacturing environment
• Willingness to learn new processes and adapt to changing operational need

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