PRIMARY RESPONSIBILITIES  

• Operate, assemble, disassemble, clean, and maintain pharmaceutical manufacturing equipment including blenders, mixers, granulators, roller compactors, tablet compression machines, encapsulators, and coating equipment in accordance with approved SOPs and cGMP requirements. 

• Support and execute R&D/Technical Services projects, including registration batches, engineering/technical batches, process validation (PPQ) activities, packaging validation studies, technology transfer, formulation and process development, process scale-up, process optimization, and commercial manufacturing troubleshooting. 

• Prepare, review, and complete batch records, equipment logbooks, cleaning records, laboratory notebooks, and other GMP documentation accurately and in a timely manner. 

• Perform equipment setup, operation monitoring, in-process sample container preparation, in-process sampling, material handling, cleaning verification, and line clearance activities to support batch execution as directed by manager. 

• Support data auditing and verification of technical documents, including protocols, reports, technical assessments, batch and study summaries, inter-office correspondence, and other project-related documentation. 

• Assist in preparation of protocols, reports, investigations, technical assessments, and validation documentation. 

• Perform data entry, data verification, proofreading, and document review activities to support accurate, compliant, and right-first-time preparation of R&D and Technical Services deliverables. 

• Prepare tables, charts, and summaries using Microsoft Excel, JMP, or similar tools to support Technical Services and R&D projects. 

• Compile, organize, trend, and analyze batch, process, and analytical data for inclusion in technical reports and presentations. 

• Maintain compliant cGMP documentation practices, ALCOA+ data integrity standards, laboratory notebook documentation, and accurate recordkeeping in accordance with approved procedures and quality system requirements. 

• Participate in formulation and process development activities, including material characterization, process evaluation, scale-up support, process optimization, and manufacturing investigations. 

• Build productive working relationships with cross-functional teams including Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, Engineering, and Technical Services. 

• Complete required training and maintain proficiency in departmental procedures, SOPs, GMP requirements, safety practices, and assigned equipment operation. 

• Assist with onboarding and hands-on training of new employees while promoting safe work practices and a collaborative team environment. 

• Comply with all environmental, health, safety (EHS), PPE, and company policies while maintaining a clean and organized work environment. 

• Maintain flexibility to support project schedules and manufacturing requirements, including extended hours, evenings, weekends, and 2nd/3rd shift operations when required. 

• Perform other duties, assignments, and special projects as required to support departmental and business objectives. 

QUALIFICATIONS/REQUIREMENTS 

• 2+ years of experience working in a cGMP manufacturing environment. 

• Strong knowledge of cGMP guidelines, SOPs, and Batch Records. 

• Experience with pharmaceutical manufacturing equipments 

• Experience in one or more of the following areas is required or strongly preferred: Technical Services, Process Engineering, Process Validation, Formulation R&D, Analytical R&D, Quality Control, Manufacturing, Packaging, or related pharmaceutical operations. 

• Experience supporting laboratory-scale and/or production-scale manufacture of solid oral, liquid, or semi-solid dosage forms is preferred. Familiarity with equipment such as mills, high-shear granulators, fluid beds, blenders, tablet presses, coaters, encapsulators, mixers, homogenizers, pumps, and packaging equipment is beneficial but not required for all candidates. 

• Experience with sampling, physical testing, in-process checks, batch record review, analytical data review, data trending, or data verification is preferred. 

• Technical writing experience and the ability to prepare clear, accurate, and well-organized protocols, reports, tables, charts, and summaries are required. 

• Good computer, mathematics, and data handling skills are required. Experience with Microsoft Office applications is required; experience with TrackWise and statistical or data analysis software such as JMP, Minitab, StatGraphics, or similar tools is preferred. 

• Demonstrated attention to detail, sound documentation practices, professional demeanor, and effective verbal and written communication skills are required. 

• Ability to work independently under general direction while also working effectively in a cross-functional team environment. 

• Ability to manage multiple assignments, organize priorities, and meet established project timelines in a high-demand environment. 

• Ability to work in laboratory and production environments under required gowning, PPE, and respiratory protection conditions, as applicable. 

• Mechanical aptitude, problem-solving skills, curiosity, resourcefulness, and a continuous-improvement mindset are preferred.