INCOG BioPharma Services Careers - Senior Process Engineer (Filling)

INCOG BioPharma•Fishers, IN

40d

About The Position

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.

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.

Nice To Haves

CMO/CDMO experience
Technical and/or lean six sigma certifications
Experience with isolator technology

Responsibilities

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.