Senior Engineer/Scientist

As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people's lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

Working as one to help many.

POSITION SUMMARY

The Senior R&D Engineer serves as a technical leader to develop manufacturing processes for complex dosage pharmaceuticals. Works cross-functionally to define and execute technical plans associated with feasibility and development work, with a focus on hands-on experimentation, process characterization and optimization, development of batch records, and overseeing clinical builds.

This position operates independently and under occasional guidance from management or senior staff. The position provides experience and expertise to, and may directly supervise, technicians and/or junior staff.

The Senior R&D Engineer ensures ProMed's brand, philosophy, systems, policies, and procedures are properly implemented and observed.

ESSENTIAL DUTIES & RESPONSIBILITIES

Position duties and responsibilities include, but are not limited to the following:

Lead process development projects (50%)

• Partner with Business Development to create technical proposals for customer projects
• Take independent ownership of process development and process control for large development and clinical projects
• Lead design, execution, and analysis of DoEs to deliver efficient, manufacturable processes
• Develop test methods, standard operating procedures, and batch records
• Analyze and synthesize data to make key process decisions
• Collaborate with clients and Technical Operations to scale up processes to meet clinical and commercial needs

Lead and contribute to feasibility projects (25%)

• Take ownership of multiple, concurrent feasibility projects
• Creatively develop pilot processes to make products that meet customers' requirements
• Optimize and understand processes
• Lead technical problem solving and improvement efforts
• Identify new technical resources to expand knowledge and grow expertise

Document and communicate (25%)

• Collaborate with Project Management, Technical Operations, Analytical Development, and Quality to complete key documentation tasks
• Maintain thorough and compliant electronic laboratory notebooks
• Create drafts of batch records, materials specifications, and testing protocols
• Author reports and presentations for internal teams and clients
• Communicate effectively with a wide variety of partners and audiences

This job also requires performing other duties as assigned.

QUALIFICATION, EDUCATION & EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• B.S. (+6 years of experience), M.S. (+3 years of experience), or Ph.D. in an engineering or physical science field
• Nine years of experience in a regulated environment in lieu of education requirements

Preferred:

• Strong knowledge of polymer or pharmaceutical processing equipment and phenomena
• Experience developing manufacturing processes for pharmaceutical or combination products
• Proficiency in statistical analysis and software; expertise in statistics preferred
• Strong problem solving and critical thinking skills
• Strong interpersonal, written, and verbal communication skills in a variety of environments

ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.