Process Engineer

We are seeking to hire a Process Engineer to join our Technical Services Team…

If any of the below describes you, we would love to meet you! 

JOB SUMMARY

Preform Product development, Process improvement, Scale up and Validation activities as mandated by cGMP’s policies/procedures and Frontida’s quality standards.  Assist operations and quality units as necessary.  Monitors Technicians, operations and quality personnel during development, validation and scale-up activities, as necessary.  The Process Engineer, under limited direction and supervision, will assist in scale-up, technology transfer projects by designing and writing Batch Manufacturing Record, Protocols, Preparing FMEA (Failure Mode Effect Analysis), Execution, writing Summary Reports and Trouble Shooting.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

• 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 pf 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

REQUIRED SKILLS AND QUALIFICATIONS

• 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, rations, 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

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES