Technician, Research and Development

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 55,000 - 85,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Technician, Research and Development to support Technical Services activities, including registration batches, process validation, technology transfer, formulation and process development, scale-up, and commercial manufacturing support for solid, semi-solid, and liquid dosage forms. The role combines hands-on batch work with documentation and data analysis.

The ideal candidate has 2+ years in a cGMP environment, strong writing and data handling skills, and

Qualifications

• 2+ years of experience in a cGMP manufacturing environment.
• Experience with pharmaceutical manufacturing equipment.
• Experience in Technical Services, Process Engineering, Process Validation, Formulation R&D, Analytical R&D, Quality Control, Manufacturing, or related pharmaceutical operations.
• Experience supporting laboratory-scale and/or production-scale manufacture of dosage forms is preferred.
• Technical writing experience and ability to prepare clear protocols, reports, and summaries are required.

Responsibilities

• Operate, assemble, disassemble, clean, and maintain pharmaceutical manufacturing equipment in accordance with SOPs and cGMP.
• Support R&D/Technical Services projects including registration batches, process validation, technology transfer, formulation and process development, scale-up, and troubleshooting.
• Prepare, review, and complete batch records, equipment logs, cleaning records, notebooks, and other GMP documentation.
• Perform in-process sampling, data verification, and handling of materials to support batch execution.
• Assist with data auditing and verification of technical documents and reports.

Skills

cGMP

Batch Records

Data analysis

Technical writing

Analytical R&D

Process Validation

Formulation R&D

Quality Control

Equipment

Microsoft Office

Tools

JMP

Minitab

StatGraphics

TrackWise

Job description

Be the First to Apply Division Piramal Pharma Solutions Piramal 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

Job Title Technician, Research and Development

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.

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 record‑keeping 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.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over‑the‑counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, colour, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.