San Diego Metro Area, CA
The successful Sr. Process Engineer will be responsible for providing technical support to Operations, Automation, Facilities Engineering, Product Development, Quality, and Regulatory Affairs. This position will focus on leading projects for improving and optimizing operations through implementation of new technology, providing support in areas such as data analysis identification of potential process bottlenecks and vulnerabilities, investigations into process abnormalities, and troubleshooting. This position will be responsible for leading capital projects from concept to implementation. Knowledge of cGMPs is essential. Experience with GMP manufacturing and technical transfer is essential.
Lead and Participate in troubleshooting and start-up of Process Equipment.
Travel is required at a minimum of 25% based on project timelines.
Provide on-call support for Operations on an as needed basis.
Lead capital and expense projects, including new equipment and equipment upgrades.
Lead cross functional teams dedicated to process improvement, efficiency, and optimization.
Provide technical assessments for investigations, validation, and change controls.
Manage corrective actions as a result of investigations.
Execute engineering studies and comparability protocols for operations.
Generate and revise control documents to support process equipment and manufacturing processes.
Participate in technology transfer within the company and to partners.
Support GMP audits from regulatory agencies as well as internal audits.
Support Capital Project work as required.
The qualified candidate will possess the following:
Minimum 10 years of relevant cGMP and technical experience
Must have a BS degree in Engineering
Knowledge of Bulk, Fill, CIP, and SIP process preferred.
Experience with production and pilot-scale pharmaceutical/ biopharmaceutical process equipment
Ability to solve issues through DOE.
Ability to work effectively, both independently and as an integral contributor toward achievement of project and company goals.
Ability to manage multiple responsibilities with a high degree of self-motivation.
Excellent and consistent organizational skills.
Must have proficient oral and written English communication skills.
Ability to work and comply with cGMP requirements
Good observation skills and problem solving ability
Team Player attitude: The willingness to work with peers towards company and department goals with dedication and willingness to do what is necessary to get the job done well and on time.
Excellent communication skills (oral and written).