Job Description

Join a multi-disciplinary team supporting the cGMP production of clinical-scale Active Pharmaceutical Ingredients (APIs). In this hands-on manufacturing role, you'll support API development through equipment operation, batch execution, documentation, and continuous improvement activities.

Typical process operations include:

• Charging solids and liquids to vessels
• Distillation, extraction, and phase separation
• Crystallization, filtration, and drying
• Equipment cleaning and preparation

Key Responsibilities

• Execute process instructions and batch records in a cGMP environment.
• Prepare, operate, monitor, sample, and clean pharmaceutical manufacturing equipment.
• Support equipment commissioning, qualification, and troubleshooting activities.
• Complete manufacturing documentation, including batch records, cleaning records, and in-process sampling documentation.
• Follow cGMP, safety, environmental, and site procedures at all times.
• Report deviations, safety concerns, and quality observations promptly.
• Manage manufacturing waste according to approved procedures.
• Participate in shift handovers and maintain clear communication across teams.
• Collaborate with Quality, Compliance, Process Chemistry, Tech Transfer, and Production teams.
• Support SOP reviews and continuous improvement initiatives.
• Manage priorities independently and assist less-experienced team members as needed.
• Complete required training and participate in site safety programs.
• Perform routine material handling activities, including lifting and moving items up to 50 lbs.

Qualifications

• High School Diploma or GED required.
• 4+ years of experience in pharmaceutical, chemical, biotech, or related manufacturing environments.
• Experience working in a cGMP-regulated setting.
• Working knowledge of production control systems and manufacturing operations.
• Strong troubleshooting, problem-solving, and critical-thinking skills.
• Highly organized with strong attention to detail and the ability to manage multiple priorities.
• Ability to work independently while collaborating effectively within cross-functional teams.
• Comfortable working in a manufacturing environment, including standing for extended periods, wearing required PPE, handling hazardous materials, and lifting up to 50 lbs.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Office applications, including Word and Excel.
• Authorization to work in the United States without current or future sponsorship requirements.

_ Preferred Qualifications:_

• Associate degree (Science or technical discipline)
• Strong mechanical aptitude and desire to execute hands on manual labor
• Experience with Delta V Production Control System
• Experience in a Pharmaceutical cGMP manufacturing environment
• Experience performing large scale distillations / Filtrations / milling

Additional Information

• After the initial training period of approximately 3 months which will be Monday- Friday from 8am-5pm, team members move to swing shift, which alternates between 1st shift and 2nd shift:

  • 1st Shift is Mon-Fri, 6:00 am to 2 pm

  • 2nd Shift is Mon – Thurs, 2 pm to 12 pm

• May be requested to work on weekends, overtime, and holidays based on business needs.

• Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options

• Life and disability insurance

• 401(k) with company match

• Paid vacation and holidays

• LinkedIn: #LI-EB1

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.