Sr Process Engineer
Hands-on engineering position with independent responsibility for developing and improving drug manufacturing processes, overseeing new product scale-up process optimization, supporting process validation and technology transfers, selecting raw material suppliers, producing supplies for clinical trials, and writing documentation for FDA applications. Products are primarily semi-solids and liquids for topical and transdermal drug delivery, including drug/device combination products. Candidate must be self-motivated as this engineer will work under general supervision on a small team.
Essential Duties & Responsibilities:
- Work within a cGMP quality system
- Collaborate with formulators to develop small and large scale drug product manufacturing processes
- Select raw materials and packaging suppliers for pharmaceutical use and maintain specification documents
- Collaborate with laboratory and manufacturing groups, including contract organizations
- Analyze and troubleshoot problems, identify solutions, and recommend and implement methods, procedures, systems and/or techniques for resolution.
- Statistical data analysis and design of experiments
- Prepare various documents, including product specifications, manufacturing batch records, experimental protocols, electronic notebook entries, technical reports, SOPs, and FDA applications
- Coordinate, supervise, and participate in manufacturing of batches for use in clinical and stability studies
- Perform risk assessments for manufacturing processes, formulations, and device designs
- Analyze, defend and present data and information acquired in process development
- Conduct investigations into manufacturing problems and implement corrective and preventive actions
- Participate in design control activities for drug/device combination products
- Function as an individual contributor, with little or no supervision on selected projects
- Perform necessary engineering projects and assignments and implement goals, objectives and practices for effective, efficient and cost effective management of allocated resources
- Ability to work in a manufacturing environment with hazardous materials and industrial equipment
Knowledge of (Preferred) – Additional Responsibilities:
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA) and other regulatory requirements
- Engineering principles applied to the manufacturing process including a wide array of topical, transdermal and aerosol products
- Experience in extrusion (twin-screw or similar) is helpful
- Packaging equipment systems
- Pharmaceutical principles, practices and applications
- Pharmaceutical quality control and manufacturing processes
- Techniques of sampling, testing and measuring, and principles of mathematical and statistical computations
- Chemical, mechanical and electrical concepts
- Statistical process control
- Time management skills to work on multiple projects simultaneously
- Leading, coordination, delegating assignments and reviewing the work of assigned personnel
- Personal computer operations and Microsoft applications (Word, Access, and Excel)
- Excellent communication skills, both written and verbal
Qualifications
A minimum of a Bachelor’s degree in engineering or a related field from an accredited college or university and at least seven or more years of process engineering experience, preferably in pharmaceutical, food, or cosmetic manufacturing environment; or an equivalent combination of education, training and experience.