Technician, Research and Development

Piramal Pharma Limited; Sellersville (Bucks County); On-site; USD 52,000 - 68,000; Full time

Job summary

Piramal Pharma Solutions is hiring a Technician, Research and Development to support manufacturing and development activities across the drug life cycle. The role involves operating cGMP equipment, maintaining records, and assisting with process development and validation projects.

The candidate should have 2+ years in a cGMP setting, strong documentation skills, and experience with lab-scale or production-scale dosage form manufacture.

Qualifications

• 2+ years in a cGMP manufacturing environment.
• Strong knowledge of cGMP guidelines, SOPs, and Batch Records.
• Experience with pharmaceutical manufacturing equipment.
• Experience in areas like Technical Services, Process Engineering, Process Validation, Formulation R&D, Analytical R&D, QC, Manufacturing, or related pharma operations.
• Experience with lab-scale or production-scale manufacture of solid oral, liquid, or semi-solid dosage forms is preferred.

Responsibilities

• Operate and maintain pharmaceutical manufacturing equipment per SOPs and cGMP.
• Support R&D/Technical Services projects including batches, process validation, tech transfer, formulation and process development.
• Prepare batch records, equipment logs, cleaning records, notebooks, and other GMP documentation.
• Assist with data auditing and verification of technical documents.
• Prepare protocols, reports, investigations, and validation documentation.
• Perform data entry, data verification, and document review to ensure accuracy and compliance.
• Create tables, charts, and summaries using Excel, JMP, or similar tools.
• Compile and analyze batch and process data for technical reports and presentations.
• Maintain ALCOA+ data integrity and compliant documentation practices.

Skills

cgmp compliance

data handling

technical writing

independent worker

cross-functional teamwork

Tools

JMP

Minitab

StatGraphics

TrackWise

Microsoft Office

Job description

Division

Piramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Technician, Research and Development

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.