Process Engineer

Philadelphia, PA

About the position

Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery! Join our mission at Adare!

Responsibilities

• Responsible for driving all aspects of project planning and material ordering.
• Execution of experimental batches, creating batch manufacturing record and FMEA creation and follow up through approval of documents.
• Evaluation of experimental batches data and providing primary conclusion.
• Author, review, revise, or approve Standard Operating Procedures (SOP’s) or other documents as required.
• Interface with Manufacturing, Packaging, Logistics, and Engineering to facilitate and drive documents review and approval.
• Provide support for scale-up, technology transfer and commercial projects.
• Follow cGMPs, safety procedures, DEA procedures, department SOPs and company policies.
• Participate on cross-functional team that address specific problems, facilitate discussion and research, enabling procedures to become more efficient, and to build and enhance interdepartmental relationships.
• Perform investigations on deviations and troubleshoot as and when required.
• Assist department in other assigned functions as required.
• Prepare protocols, manufacturing batch records, ensure sampling and testing are completed as planned, executing manufacturing batch records and evaluate all in-process and analytical data and write reports.
• Coordinate cleaning and manufacturing activities with company Quality Units, Operations, R&D, etc for commercial or R&D products.
• Coordinate and execute the manufacturing of projects associated with alternative source of raw materials, new product development, product and process optimization batches, etc.
• Upon the completion of product processing, ensure robustness of the process and formulation which will support any NDA/ANDA filing.
• Review, as necessary, all pertinent documentation, cleaning procedures, batch history and technical transfer reports prior.
• Attend team meeting Process Operations representative as required.
• Work with the R&D Formulator on the process development of projects.
• Perform other duties as assigned.

Requirements

• B.S. in Pharmacy or Bachelor Degree in relevant Science/Engineering discipline, Masters in Pharmaceutical Engineering is plus.
• Technical understanding and hands on experience of pharmaceutical unit operations.
• Proficiency with Quality by Design (QbD) concepts, statistical process control (SPC) and complex data analysis.
• Hands on experience using statistical data analysis tools.
• Computer skills and Microsoft Work, Excel, PowerPoint.
• Good planning and coordination skills and able to adapt to changes in priorities and project schedules.
• Quality and attention to detail in documentation work and reports.
• Strong written communication skills, creativity and enthusiasm.
• Ability to work well in a team setting and work on multiple projects.
• Clearly present data in team meetings.
• Good knowledge of cGMP requirements and current industry practices.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Nice-to-haves

• Masters in Pharmaceutical Engineering.

Benefits

• Medical/dental/vision/life – low employee premiums.
• 401k with a highly competitive match.
• Generous PTO, including floating holidays.
• Career growth and internal opportunities.
• Tuition reimbursement.
• Relocation assistance.
• Performance-based bonus.
• Employee Recognition Programs.