Senior Process Engineer (Filling)
Description
Process Engineer Summary
INCOG BioPharma is seeking a highly motivated individual with extensive capabilities in process engineering and manufacturing of injectable drug products. The ideal candidate must have experience in
technical roles within biopharmaceutical based GXP manufacturing operations including technology transfers and process/equipment improvements related to aseptic filling.
The successful candidate will provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to equipment lifecycle, qualification, audit responses, and validation to meet regulatory requirements. Shall have excellent oral/written communication skills and strong technical writing ability to lead and/or participate on teams with internal partners, customers, and vendors. Additionally, the candidate must thoroughly understand and be able to adapt to the changing needs of a contract manufacturing environment.
Essential Job Functions
· Monitor and analyze manufacturing data to support process improvement, investigations, and system requalification.
· Lead and execute decontamination protocols standardized across all filling and packaging lines.
· Participate in and support process FMEAs to identify process/product risks as a prerequisite for validation, with emphasis on aseptic filling equipment, containment systems, and controlled environments.
· Mentor and train team members on sterilization technologies, equipment requalification, and aseptic practices.
· Ensure successful manufacturing process comparability and validation runs by assessing risk, setting preventative measures, investigating, and troubleshooting filling equipment, air handlers, control loops, and sterile systems.
· Lead and ensure systematic DMAIC-based approach utilization for process/product-related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.
· Serve as primary technical interface on cross-functional teams to advance production activities and resolve equipment/process deviations.
· Evaluate and implement new technology and automation (e.g., advanced sterilization, filling systems) into GMP manufacturing.
· Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing)
· Execute engineering studies, recipe development, and validation test cases for aseptic filling lines, packaging systems, and containment solutions.
· Collaborate with vendors/suppliers to define requirements and verify functional specifications for sterilization, decontamination, and environmental control systems.
· Adapt quickly to evolving client and manufacturing needs in a CDMO environment; flexible hours required to support 24/7 production.
Special Job Requirements
· 5+ years’ experience in biopharmaceutical or other GXP-regulated industry.
· Bachelor’s degree or higher in an Engineering field.
· Hands-on experience with autoclaves, VHP sterilization, requalification, and decontamination systems.
· Background in aseptic/sterile manufacturing environments.
· Proven ability to work in client-facing settings and communicate complex technical issues clearly to non-technical stakeholders.
· Knowledge of data management tools and RCM.
Additional Preferences:
· CMO/CDMO experience
· Technical and/or lean six sigma certifications
· Experience with isolator technology
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.