Process Operator

ALLTECH CONSULTING SVC INC; Pennsylvania; On-site; USD 35,000 - 50,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Process Operator to join their team in Pennsylvania. The role involves micronizing and milling materials while adhering to stringent safety and quality standards. Candidates should possess a High School Diploma or GED and demonstrate eagerness to learn in a regulated environment, fulfilling both physical and compliance-related responsibilities.

Qualifications

• Dependable and eager to learn, able to meet physical requirements.
• Prior manufacturing and regulated environment experience preferred.
• Ability to work weekday and weekend overtime is a plus.

Responsibilities

• Perform entry-level micronization and milling of hazardous materials.
• Set up and operate production equipment while monitoring processes.
• Report production on batch records and maintain documentation.

Skills

Effective oral and written communication

Basic math skills and interpretation

Education

High School Diploma or GED

Job description

Job Description:

The Process Operator micronizes/mills client-provided material, including active pharmaceutical ingredients and excipients, following our procedures, policies, client instructions, and cGMP guidelines. Demonstrates company values and leadership behaviors in all interactions.

Operator Responsibilities:

1. Perform entry-level micronization and milling of hazardous and non-hazardous pharmaceutical actives and excipients.
2. Set up, operate equipment, and monitor production processes.
3. Report production on batch records adhering to good documentation practices (GDPs).
4. Work in a regulated environment, following standard operating procedures and policies.
5. Adhere to cGMP standards.
6. Identify and report non-routine events, deviations, and GMP deficiencies promptly to the supervisor.
7. Clean the processing area and equipment thoroughly.
8. Maintain clear, consistent documentation in compliance with quality standards.
9. Show willingness to learn and adapt to new processes.
10. Ask questions or suggest improvements when needed.
11. Participate in shift change meetings, team discussions, email communications, and projects.
12. This is a site-based position.
13. Strive for First Time Right (FTR) to meet annual KPIs.
14. Stay current with Compliance Wire and other site training.
15. Perform additional duties as assigned by management.

Performance Measures:

• Adherence to safety and quality procedures.
• Product quality, throughput, and yields.
• Attendance, punctuality, and dependability.
• Work ethic and attitude during daily operations.

Position Requirements:

Education or Equivalent:

High School Diploma or GED.

Experience:

Dependable, eager to learn, able to meet physical requirements. Prior manufacturing and regulated environment experience preferred. Ability to work weekday and weekend overtime is a plus.

Knowledge/Skills:

• Effective oral and written communication.
• Basic math skills and interpretation.
• Potential exposure to hazardous chemicals with proper PPE.
• Experience with production is preferred.

Physical Requirements/Work Environment:

• Physical strength, stamina, and dexterity, including wearing PPE.
• Ability to lift/move up to 44 lbs alone, or with assistance for heavier loads.
• Work safely with HPAPI and unknown potency compounds.
• Perform moderate physical labor: lifting, climbing, bending, crouching, reaching, twisting.
• Stand or walk up to 8 hours daily.
• Climb steps/ladders and work at heights occasionally.
• Wear respirator hoods and pass medical exams.
• Work in loud environments with hearing protection.
• Handle chemicals and hazardous materials safely according to safety protocols.