Manufacturing - Process Operator I

Ampcus, Inc; Malvern (Chester County); On-site; USD 30,000 - 45,000; Full time

Job summary

Ampcus, Inc in Malvern seeks a Manufacturing Process Operator I to perform entry-level micronization and milling tasks for pharmaceutical materials, adhering to rigorous cGMP standards. Candidates are expected to set up and monitor equipment, while documenting their production in compliance with good documentation practices.

This role requires a high school diploma or GED, along with dependability, eagerness to learn, and the ability to meet the physical demands of the job, including lifting up to 44 lbs. Personal protective equipment will be provided. Join our dynamic team and help us achieve excellence.

Qualifications

• Must be dependable and eager to learn.
• Prior manufacturing experience preferred.
• Ability to meet physical job requirements.

Responsibilities

• Perform micronization and milling of pharmaceutical materials.
• Set up and operate equipment while monitoring processes.
• Document production accurately following GDPs.
• Adhere to cGMP standards and company procedures.

Skills

Dependable

Communication Skills

Basic Math Skills

Ability to lift or move items up to 44 lbs.

Ability to work safely with HPAPI

Education

High School Diploma or GED

Job description

Job Title: Manufacturing - Process Operator I

Location: 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.