Manufacturing - Process Operator I

Ampcus Inc; Malvern (Chester County); On-site; USD 42,000 - 65,000; Full time

Job summary

Ampcus is seeking a Manufacturing - Process Operator I in Malvern to join our sterile manufacturing team. The role performs micronization and milling of pharmaceutical actives and excipients, following client Malvern procedures and cGMP guidelines.

You will set up and operate equipment, document batch records, work in a regulated environment, and support continuous improvement while complying with safety and PPE requirements.

Qualifications

• High School Diploma or GED.
• 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 overtime a plus.
• Technical Skills/Knowledge including Communication Skills, Basic Math Skills, and interpretation.
• Potential limited exposure to health and physically hazardous chemicals.
• Personal protective equipment is provided and required in designated areas.
• Physical strength, stamina, and dexterity required. Lift up to 44 lbs.
• Ability to work safely with HPAPI.
• Prolonged standing, lifting, bending, and climbing as part of moderate physical labor.
• Work in loud environments with hearing protection.

Responsibilities

• Perform entry-level micronization and milling of actives and excipients.
• Set up, operate equipment, and monitor production processes.
• Report production on batch records following GDPs.
• Work in a regulated environment with SOP adherence.
• Identify and communicate deviations and GMP deficiencies to supervisor.
• Maintain clean processing areas and equipment.

Skills

Communication Skills

Basic Math Skills

Interpretation

Education

High School Diploma or GED

Job description

Job Title

Manufacturing - Process Operator I

Location(s)

client Malvern

Job Summary

The Process Operator is responsible for micronizing and milling client-provided materials, including both active pharmaceutical ingredients and excipients, in accordance with client Malvern procedures, client instructions, and cGMP guidelines. The role requires consistent modeling of client values and leadership behaviors.

Key Responsibilities

• 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.
• Strive to achieve First Time Right (FTR) as a key performance indicator (KPI) in order to meet our yearly targets.

Required Qualifications

• High School Diploma or GED.
• 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 overtime a plus.
• Technical Skills/Knowledge including Communication Skills, Basic Math Skills, and interpretation.
• Potential limited exposure to health and physically hazardous chemicals.
• Personal protective equipment is provided and required in designated areas.
• Physical strength, stamina, and dexterity required. Ability to lift or move items up to 44 lbs. individually, or with assistance for heavier items.
• Ability to work safely with high potency active pharmaceutical ingredients (HPAPI).
• 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 and work in loud environments with hearing protection.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.