Process Engineer I

$79,040 - $85,280/Yr

Ihire - Frederick, MD

Full-time - Entry Level

Frederick, MD

10,001+ employees

Administrative and Support Services

About the position

Innova Solutions is immediately hiring for a Process Engineer I position located in Frederick, Maryland. This is a full-time contract role with a duration of 12 months. The selected candidate will be part of the Operations and Compliance Support team, focusing on innovative T-Cell therapies for cancer treatment. The role requires a highly motivated individual with a background in biotechnology to assist in the examination and resolution of adverse events that occur within manufacturing operations for engineered T-Cell therapy products. As a Process Engineer I, you will be responsible for maintaining technical skills and knowledge in compliance with current Good Manufacturing Practices (cGMP). This includes initiating quality records in the Veeva Quality Management System (QMS) and leading cross-functional team meetings to perform complex root cause analysis (RCA). You will compile investigation results into comprehensive technical reports and collaborate with stakeholders to develop Corrective and Preventive Actions (CAPA). Additionally, managing investigation timelines to meet site compliance metrics and providing timely progress updates to internal stakeholders will be key aspects of your role. The position requires a strong foundation in biochemical engineering or related fields, along with relevant experience in the biotechnology sector. Candidates will be expected to demonstrate strong technical writing skills, organizational abilities, and proficiency in root cause analysis, particularly in the context of cell culture or aseptic processing. Experience in cGMP cell therapy manufacturing is also preferred.

Responsibilities

• Complete required training to maintain technical skill, knowledge, and compliance with cGMP requirements.
• Initiate quality records in the Veeva Quality Management System (QMS).
• Lead cross-functional team meetings to perform complex root cause analysis (RCA).
• Compile investigation results in a concise and comprehensive technical report format.
• Collaborate with stakeholders to develop Corrective and Preventive Actions (CAPA).
• Manage investigation timelines to meet/exceed site compliance metrics for closure adherence.
• Provide timely progress updates to internal stakeholders, as required.

Requirements

• BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 2 years of relevant experience.
• AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 6 years of relevant experience.
• HS Diploma with 8 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent.

Nice-to-haves

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

Benefits

• Medical & pharmacy coverage
• Dental/vision insurance
• 401(k)
• Health saving account (HSA)
• Flexible spending account (FSA)
• Life Insurance
• Pet Insurance
• Short term and Long term Disability
• Accident & Critical illness coverage
• Pre-paid legal & ID theft protection
• Sick time
• Employee Assistance Program (EAP)