Technician, Research and Development

Piramal Pharma Ltd•Sellersville, PA

63d•Onsite

About The Position

The Technician supports the R&D organization, with primary alignment to Technical Services activities, including registration, validation, technology transfer, process scale-up, process optimization, formulation and process support, and commercial production support for solid, semi-solid, and liquid pharmaceutical dosage forms. The role combines hands-on batch support with technical documentation, data compilation, data verification, protocol execution, in-process sampling/testing support, and preparation of tables, figures, and report content. The ideal candidate has experience in either pharmaceutical manufacturing/process support or laboratory/analytical testing, with the ability and willingness to support both floor-based and office-based R&D and Technical Services activities as project needs require.

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.
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.
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.

Nice To Haves

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

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.