Production Operator II
Curia
Summary
Support timely manufacturing of parenteral cGMP products in an aseptic environment including executing and supporting formulation operations in a GMP-regulated environment. This role performs complex processing activities, supports troubleshooting and process improvements, and contributes to documentation development and technical writing efforts to ensure compliant and efficient manufacturing operations.
Job description
Responsibilities
- Execute and support complex formulations and compounding operations according to batch records and SOPs
- Operate and monitor formulation equipment including mixers, tanks, filtration systems, and transfer systems
- Ensure adherence to GMP, safety, and data integrity requirements
- Support process scale-up, engineering runs, and GMP batches
- Assist in drafting and revising SOPs, batch records, and protocols
- Review batch record documentation for accuracy and completeness
- Support technical transfer and process documentation updates
- Prepare and sanitize equipment for clean rooms, product compounding, and filling according to preparation list, including disassembly/assembly
- Load and unload steam sterilizers and washers according to diagrams and instructions
- Record all procedures in logbooks following completion and complete/correct batch records
- Sanitize aseptic/controlled production areas to ensure microbial contamination is reduced to safe level on inanimate surfaces
- Bubble point test filters and read/interpret SOPs to ensure compliance
- Other duties as assigned
Required
- High school education or equivalent
- One year of experience in pharmaceutical manufacturing
Preferred
- Associate’s degree or biotechnology certificate; biotechnology certificate may be substituted for the equivalent combination of experience in the industry
- Previous cleanroom or cGMP experience
Other Skills and Abilities
- Comprehend and follow SOPs, cGMPs, and detailed instructions to successfully produce sterile quality products
- Document information, events, and cGMP manufacturing processes clearly, accurately and completely
- Perform duties in an organized, detail-oriented manner
- Apply basic math: measures, weights, fractions, decimals
- Apply basic computer skills
- Work and communicate well with others in a team environment
Requirements
- High school education or equivalent
- One year of experience in pharmaceutical manufacturing
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
- Ability to write routine reports and correspondence
- Ability to speak effectively before groups of customers or employees
- Ability to add, subtract, multiply, and divide in all units of measure
- Ability to compute rate, ratio, and percent and to draw and interpret bar graphs
- Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form
- Knowledge of Internet software; Manufacturing software; Spreadsheet software and Word Processing software
- Comprehend and follow SOPs, cGMPs, and detailed instructions
- Document information, events, and cGMP manufacturing processes clearly, accurately and completely
- Perform duties in an organized, detail-oriented manner
- Apply basic math: measures, weights, fractions, decimals
- Apply basic computer skills
- Work and communicate well with others in a team environment
- Must pass background check
- Must pass drug screen
- May be required to pass Occupational Health Screening
- May be required to obtain and maintain gowning certification
- May be required to obtain and maintain media qualification
Benefits
- Generous benefit options
- Paid training
- Paid vacation
- Paid holidays
- Career advancement opportunities
- Education reimbursement
- 401(k) Matching
- Learning platform
Company overview
Curia is a leading global Contract Development and Manufacturing Organization (CDMO) with over 30 years of experience in the pharmaceutical industry. Headquartered in Albany, New York, the company operates an integrated network of 25 global sites across North America, Europe, and Asia, employing approximately 3,500 professionals. Curia provides comprehensive end-to-end solutions spanning drug discovery, development, and manufacturing services for both small molecules and biologics. Their expertise covers active pharmaceutical ingredient (API) manufacturing, sterile drug product development, analytical testing, and regulatory support. The company specializes in complex areas including high-potency compounds, controlled substances, sterile APIs, and mRNA manufacturing. With state-of-the-art GMP facilities and a strong focus on innovation, Curia partners with pharmaceutical and biotechnology companies to accelerate the development and commercialization of life-changing therapeutics, from early-stage discovery through commercial-scale production.