Apply on Employer Site

INCOG BioPharma Services · 1 month ago

Senior Process Engineer (Filling)

Fishers, IN

Full-time

Onsite

Senior Level

5+ years exp

INCOG BioPharma is seeking a highly motivated individual with extensive capabilities in process engineering and manufacturing of injectable drug products. The successful candidate will provide technical assessments and approval for engineering and process changes while ensuring compliance with regulatory requirements in a contract manufacturing environment.

BiopharmaBiotechnologyManufacturingPharmaceutical

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

Qualification

Process engineeringAseptic fillingGXP manufacturingSterilization technologiesLean six sigmaTechnical writingData management toolsClient-facing communicationIsolator technologyTeam mentoring

Required

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

Preferred

CMO/CDMO experience

Technical and/or lean six sigma certifications

Experience with isolator technology

Company

INCOG BioPharma Services

Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.

Founded in 2020

Fishers, Indiana, USA

201-500 employees