myGwork - LGBTQ+ Business Community · 3 days ago
Principal Engineer, Process Engineering
Wonder how qualified you are to the job?
Maximize your interview chances
Internet
Insider Connection @myGwork - LGBTQ+ Business Community
Responsibilities
Identify and develop technical solutions to enable program and company goals.
Lead the design and implementation of efficient and scalable manufacturing processes for commercial application, working closely with cross functional teams including process development, manufacturing, and engineering. The role includes the design and execution of process scale-up strategies and technologies, with the potential to design and implement novel equipment and manufacturing platforms for cell therapy programs. This includes the assessment of advanced automated systems, including robotics, artificial intelligence, and digital data systems.
Establish process equipment selection and user requirement specifications to enable efficient facility installation and qualification.
Drive continuous improvement activities and operational excellence, including reduction of Cost of Goods Sold (COGS) and commercial robustness/reliability.
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
PhD with 5+ years, MS with 7+ years, or BS with 9+ years of experience
Significant experience leading equipment design, FAT/SATs, qualification, and validation
Experience leading projects with minimal oversite
Experience with large-scale GMP manufacturing for biopharmaceutical manufacturing, specifically facility design and process fit/transfer methodologies
Knowledge of vision or other automated inspection systems
Experience with cGMP regulations/guidance and with regulatory agency inspections preferred
Experience with inline process analytical technologies (PAT) for real-time assessment of manufacturing performance is preferred
Experience working with external partners (CMOs, vendors, etc.)
Ability to travel, nationally and internationally, up to 10 - 15%
Flexibility to work on-site a minimum of 3 days per week
Preferred
Experience with process automation/robotics
Benefits
Equal employment opportunity
Non-discrimination policy
E-Verify Employer
Company
myGwork - LGBTQ+ Business Community
myGwork is the largest global platform for the LGBTQ+ business community.
Funding
Current Stage
Early StageTotal Funding
$4.77MKey Investors
24 HaymarketInnovate UK
2023-08-17Series Unknown· $1.66M
2023-08-17Grant· Undisclosed
2021-12-07Series A· $2.12M
Recent News
2024-04-10
Company data provided by crunchbase