About this role
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 vesselsDistillation, extraction, and phase separationCrystallization, filtration, and dryingEquipment cleaning and preparationKey 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. 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 laborExperience with Delta V Production Control SystemExperience in a Pharmaceutical cGMP manufacturing environmentExperience performing large scale distillations / Filtrations / milling 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 optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysLinkedIn: #LI-EB1Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.