Employment Type: Permanent Position

Job Category: Biomanufacturing

Department: Technical Operations

Reports To (Position): Head of Technical Operations

Job Number: 3267681

Responsibilities:

• Lead compliance of 21 CFR 211 regulations for all equipment, including Manufacturing and Quality Control.
• Draft or review all validation documents related to CSV including User Requirement Specifications, Design Verifications, Qualification Protocols, and Validation Reports.
• Lead the integration, programming and automation of all MES and LIMS systems.
• Lead day-to-day, including weekends, operational support and troubleshooting activities involving automated equipment and process control systems.
• Assist in client audits when required.
• Assist with training staff on MES or LIMS systems.
• Establish a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices.
• Assist and support routine maintenance activities, if required. 
• Work cross functionally among Manufacturing, Quality Control, Quality Assurance, IT and other departments as assigned. 
• Meet and report key performance indicators in alignment with Cell Therapy Manufacturing and company goals. 
• Other duties as assigned. 

Qualifications/Skills:

• Bachelor’s degree in Computer Science, Life Sciences, or Engineering.
• 9+ yr.’s experience in related role.
• 4+ yr.’s experience in a regulated manufacturing environment.
• Experience with IT infrastructure, digital systems, and software solution deployments for biopharmaceutical business operations.
• Previous experience with MES and LIMS preferred.
• Proficient with Microsoft Office: Word, Excel, Outlook and Teams.
• Previous GMP Experience preferred.
• Previous experience with audits preferred.
• Meticulous attention to detail in terms of documentation and following SOPs. 
• Able to work a flexible schedule including nights, weekends, and holidays with short advance notice.

Working Conditions, Equipment, Physical Demands

The incumbent in this position works in an office, labs, and clean room environments. The incumbent in this position will use the following equipment and shall have the following physical demands:

Equipment-

• Computer
• Printer
• Facsimile
• Telephone
• Manufacturing equipment

Physical Demands- 

• Frequent standing, walking, sitting, and reaching required.
• Frequent lifting up to 10 lbs. required.
• Occasional lifting, pushing, and pulling up to 50 lbs. required.
• Frequent use of computer/keyboard required.

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.

The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.

Relocation Assistance: Yes