Production Operator II

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
• Language Skills 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 of organization.
• Mathematical Skills Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
• Reasoning Ability Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
• Computer Skills Knowledge of Internet software; Manufacturing software; Spreadsheet software and Word Processing software,.
• 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
• Other Qualifications • 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
• Physical Demands While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.
• Work Environment While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.
• Pay Range: $25.24-$31.97/hour
• Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
• We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
• All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia 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, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.