Process Engineer I - Frederick, MD at Hydrogen Group in Frederick, Maryland

Job Description:

Location: Frederick, MD (onsite)

Schedule: Standard Office Hours

Duration: 12-Month Contract

Pay rate: $37.00 - $41.00 per hour

Role Overview:

As part of the Operations and Compliance Support team, you will join a group of investigators dedicated to analyzing and resolving adverse events (quality events) in the manufacturing operations of engineered T-Cell therapy products.

Key Responsibilities:

• Complete necessary training to maintain technical expertise, knowledge, and compliance with cGMP requirements.
• Initiate quality records in the Veeva Quality Management System (QMS).
• Lead cross-functional team meetings to conduct detailed root cause analysis (RCA).
• Summarize investigation results in clear and comprehensive technical reports.
• Collaborate with stakeholders to develop Corrective and Preventive Actions (CAPA).
• Manage investigation timelines to meet or exceed site compliance metrics for timely closure.
• Provide regular progress updates to internal stakeholders as needed.

Basic Qualifications:

• BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or a related field with a minimum of 2 years of relevant experience, or
• AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or a related field with a minimum of 6 years of relevant experience, or
• HS Diploma with 8 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or a related field

Preferred Qualifications:

• Strong technical writing skills
• Strong organizational skills
• Strong root cause analysis skills
• Experience in cell culture or aseptic processing
• Experience in cGMP cell therapy manufacturing

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