Brooksville, FL US
- Title: Process Engineer
- Location: Brooksville, FL
- Industry: Life Science/Pharmaceutical
- Salary: Based on Experience
- Employment Type: Direct Hire
The Process Engineer has a thorough understanding and wide application of technical principles, theories, and concepts in the field.
Responsible for the management and execution of commercial product support projects in the areas of product technical transfer, product, process improvement and optimization, scale-up, troubleshooting, and investigation.
The Process Engineer will serve as a technical resource in process development, process equipment troubleshooting, process optimization, scale-up, and technology transfer in Sterile Injectables.
- Performs process equipment troubleshooting activities for daily support of manufacturing.
- Write scientific documents to support justification for process scale-up, technology transfer, and/or equipment changes.
- Support process validation batches by writing and executing process validation protocols and support Production during execution.
- Develops experimental plans for process development.
- Evaluates and develops new technologies.
- Executes experimental, clinical, stability, and validation batches.
- Provides technical review of contracted and internal formulation and development work for transfer candidate products.
- Performs root cause identification of product, process related investigations. Uses judgment, creativity, and sound technical knowledge to obtain and recommend solutions CAPAs.
- Authors development and investigation reports, protocols, specifications, procedures.
- Writes experimental, pivotal, validation, commercial batch records.
- Reviews GMP documents (MBRs, SOPs, protocols) and generates change controls.
- Assist in writing proof of principle protocols, assist in writing and developing design specifications and IQOQPQ protocols.
- Understand the operation and be able to monitor manufacturing equipment utilizing HMIs for parts washer, autoclave, vial washers, depyrogenation tunnels, fillers, etc.
- Collaborate with relevant departments in writing and executing master formula cards in support of batch improvement.
- Perform trending and monitoring of critical quality attributes, critical process parameters to maintain product quality. Utilize statistical methods to evaluate data, process control and develop sampling plans.
- Evaluate new manufacturing equipment, materials and processes; assist in review and writing of protocols, assist in reviewing design specifications and qualification protocols.
- Assist in review and writing of SOPs. Assists during the development of new products to provide a commercial operations perspective to process design and development of new products.
- Provide input regarding application of technologies that will optimize capital investment to provide robust, productive, and practical processes at commercial scale.
- Develop, evaluate and implement improvements to existing processes to optimize production output and reduce production cycle-time.
- Use critical thinking and problem solving skills to independently identify and solve technical problems related to the manufacture and packaging of products.
- Provides input in the selection of new equipment and technologies to support the plants processes.
- Support test runs, validation runs, engineering runs, and any other requirements as needed during the manufacturing work hours as applicable (be available "on call" for after hours).
- Works under limited supervision of management and/or team leads.
- Proven ability to work in a cross-cultural environment and provide technical leadership.
- Extensive background in Aseptic/Sterile Injectable processes and a clear understanding of the associated regulatory requirements.
- Exceptional communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders and technical leaders.
- Ability to lead technical programs and initiatives, fostering support from stakeholders and collaboration among participants.
- Bachelor Degree in Engineering or equivalent scientific discipline
- 5 - 10 years of experience in the Pharmaceutical / Biologics Manufacturing operations with an in-depth knowledge of Aseptic/Sterile Injectable processes and regulatory requirements.
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.