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Job Summary: The manufacturing operator is responsible for producing oral solids and liquids, ensuring compliance with Good Manufacturing Practices (GMP) and internal procedures. Key Highlights: 1. Operation and cleaning of pharmaceutical manufacturing machines and tooling 2. Verification and review of manufacturing and cleaning processes 3. Recording of activities and compliance with good documentation practices **Job Description/Position Description** The manufacturing operator is responsible for producing oral solids and liquids in accordance with Good Manufacturing Practices. Performs verification, inspection, and review of all manufacturing and cleaning processes per internal procedures. Performs general operations in the manufacturing area, such as cleaning of areas, equipment, tooling, accessories, weighing booths—all in compliance with Good Manufacturing Practices, Standard Operating Procedures, and Work Instructions. This role is based in Xochimilco, CDMX. Employment is temporary under a 12-month contract. **Responsibilities** * Operation and cleaning of manufacturing machines, tooling, or accessories—including but not limited to coating equipment such as drums, mixers, tablet presses, wet or dry granulators, drying ovens, mills, coating equipment, balances and scales for dispensing raw materials and/or active pharmaceutical ingredients (APIs), kettles and mixing tanks—with or without heating—CHILLER cooling systems, homogenizers. * Operation of equipment during manufacturing processes for solids and/or liquids involved in dispensing, granulation, mixing, compression, and coating stages. * Assembly, disassembly, cleaning, and sanitization of equipment per established procedures. * Support format changes, equipment adjustments, and line preparation. * Operation and cleaning of liquid filling machines. * Execution of general activities for conditioning and manufacturing areas. * Cleaning of conditioning and manufacturing areas. * Cleaning of equipment, tooling, and utensils in conditioning and manufacturing areas. * Verification of cleaning, clearance, and assembly processes for the aforementioned machines. * Authorized to perform verification, inspection, and review of documentation as a second person for cleaning processes and CTQ verification of production processes. * Authorized to operate SAP, PAS X, and any other software supporting production processes. * Verification of raw materials and components prior to initiating the manufacturing process. * Transport of materials inherent to manufacturing. * Supply of GMP consumables to production areas (hairnets, face masks, shoe covers, gloves, detergents, sanitizers, cleaning utensils, etc.). * Preparation of detergent solutions and sanitizer solutions used in production area activities. * Compliance with applicable corporate and national safety regulations. * Recording of activities in electronic records, paper records, logbooks, and forms per Good Documentation Practices. * Verification of balances in production areas (manufacturing, conditioning). * Active participation in TIER 1 activities in production areas. * Knowledge and execution of continuous improvement methodologies. * Identification and reporting of deviations, equipment failures, or out-of-specification conditions. * Contribution to achieving productivity, quality, and on-time delivery objectives. **Education, Experience and Required Skills** * Completed high school or equivalent with certificate. * Prior experience operating granulator machines is mandatory. * 2+ years of experience in weighing, dispensing, milling, mixing, granulation, compression, tablet coating, cleaning, and equipment assembly—including mills, mixers, granulators, tablet presses, and coating drums. * Knowledge of Good Documentation Practices (GDP). **Competencies / Required Skills:** * Completed technical career or incomplete/prospective university degree. * Knowledge of continuous improvement tools. * Familiarity with NOM-059. * Minimum 5 years of experience in primary or secondary packaging operations within pharmaceutical industries. * Knowledge of ERP systems such as SAP or similar. **Secondary Job Description** **Who We Are:** Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. **Search Firm Representatives Please Read Carefully** Organon LLC does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Annualized Salary Range** **Annualized Salary Range (Global)** **Annualized Salary Range (Canada)** **Please Note: Pay ranges are specific to local market and therefore vary from country to country.** **Employee Status:** Project Temps (Fixed Term)**Relocation:** No relocation**VISA Sponsorship:** **Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites** **Flexible Work Arrangements:** **Shift:** **Valid Driving License:** **Hazardous Material(s):** **Number of Openings:** 1 **Requisition ID:**R540325
