Our Company is experiencing rapid growth and we are seeking a Process Engineer to join our organization. This position is responsible for performing and/or leading a wide-array of manufacturing process/equipment development and engineering activities in a pharmaceutical cGMP environment. These activities include designing studies and processes, writing and executing protocols for testing equipment, product and processes, and summarizing results into technical reports. The Process Engineer will assist in troubleshooting, equipment and facility design, and managing commissioning, validation and revalidation projects.
- Lead projects or participate on project teams to develop the manufacturing process for new products and implement improvements to existing manufacturing processes
- Assist in the design and procurement of new equipment and lead commissioning, start-up, installation, or qualification activities including authoring IQ/OQ/PQ protocols, test execution, and authoring summary reports
- Design and execute studies as required to investigate, optimize, troubleshoot, and implement process improvements
- Work on multiple process development and validation projects simultaneously and coordinate test work with various other departments
- Participate in the development and implementation of procedural or automation improvement changes.
- Perform process qualification for new equipment and new technologies.
- Write procedures, protocols and technical reports for manufacturing, utility, performance qualifications, lab equipment, cleaning and process validation
- Compile validation packages and assure all required documentation is accurate and complete
- Champion process improvement projects and ensure equipment and systems remain in a qualified state
- Lead investigations and ensure thoroughness of investigation, identification of root cause, documentation and closure
- Participate in design reviews of plant expansions or process changes, and serve as a technical point of contact or user representative for contract services
- Serve as point person for process improvement activities; including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT and SAT protocols
- Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, change controls and CAPA’s through participation on cross functional teams
- Support Maintenance activities, including review and approval of preventative maintenance tasks, calibration tolerances and intervals, drawing updates, and support of out-of-tolerance investigations related to instrument calibrations
- Lead risk assessment exercises related to equipment and processes, including Failure Mode Effect Analysis (FMEA).
- Train technicians on Batch Production Records and equipment operation.
- Assist or conduct investigations to resolve deviations, including Root Cause Analysis (RCA).
Education and Experience
- BS degree in Chemistry or Chemical Engineering with emphasis on organic chemistry.
- Minimum of 2 years of previous relevant work experience in a related field required.
- Experience providing technical support in a cGMP manufacturing environment including hands-on product development, optimization and troubleshooting of equipment and processes is preferred.
- Expertise with any of the following: process equipment, filling or packaging equipment, cleaning validation planning and execution, piping and instrumentation diagrams (P&ID), chemical process engineering and pharmaceutical process development.
- Possess effective skills for developing, performing, evaluating, troubleshooting for operating systems and controls, or within a specific scientific / technical discipline.
- Excellent working knowledge of cGMPs and regulatory requirements preferred.
- Excellent technical writing and organizational skills; extremely detail oriented.
- Good mechanical aptitude.
- Good interpersonal skills and the ability to work well in a team environment.
- Self-starter with outstanding work ethic; must be able to perform in a fast paced multi-product environment.
- Ability to maintain focus on tasks until completion and think analytically to solve problems when appropriate.
- Ability to apply statistics and process capability methodologies to evaluate processes and to implement and monitor improvements.
- Strong listening, writing, reading, and verbal communication skills.
Avanti Polar Lipids, Inc. has been manufacturing the highest quality phospholipids, sphingolipids and sterols for the research and pharmaceutical industry for over 50 years. We have a unique reputation for purity that is achieved by our highly trained team of employees working together to ensure the quality of the final product.
Avanti is located in Alabaster, Alabama, a suburb 20 minutes south of Birmingham. We offer a creative and professional environment where people can succeed. Avanti was founded with one driving vision—the pursuit of perfection. At Avanti excellence is expected and rewarded. We strive to maintain an atmosphere that promotes growth and employee satisfaction.
Avanti Polar Lipids, Inc. is an equal employment / affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please contact us to let us know the nature of your request.
Job Type: Full-time
- Process Engineering: 2 years (Preferred)