Principal/Senior Principal Quality Engineer, Validation - Assembly & Packaging (Biotech)

TL;DR

Principal Quality Engineer (Pharmaceutical Validation): Providing quality oversight for validation and qualification of assembly and packaging equipment at a new high-volume drug product manufacturing facility with an accent on cGMP compliance and operational excellence. Focus on driving the qualification of automated production systems, establishing risk-based validation strategies, and ensuring successful commercial launch of CVRM medicines.

Location: Must be based in or able to work onsite in Holly Springs, North Carolina, USA

Salary: $93,000 - $210,100

Company

hirify.global is a member of the Roche group and a pioneer in the biotechnology industry dedicated to discovering and developing medicines for serious and life-threatening diseases.

What you will do

• Provide quality oversight for the validation and qualification of assembly and packaging equipment and automation systems during facility start-up.
• Represent QEV on the User Team for the qualification of all Assembly and Packaging equipment and supporting systems at the Holly Springs facility.
• Collaborate with Engineering, MSAT, Quality, Supply Chain, and Regulatory teams to design, test, and validate the Drug Product Fill and Finish facility.
• Develop and provide strategic guidance for the validation strategy for PQ and GMP start-up activities to ensure effective commercial launch.
• Champion a science and risk-based approach to Qualification and Validation across the organization.
• Coach and mentor junior colleagues and develop training materials for new staff joining the organization.

Requirements

• Location: Must be based in or be able to work onsite in Holly Springs, North Carolina, USA
• 8+ years (Principal) or 12+ years (Senior Principal) of experience in the pharmaceutical or related industry.
• Direct experience in a cGMP regulated environment focusing on equipment, facilities, and assembly and packaging systems.
• Recognized expertise in the qualification of automated production equipment for Drug Product manufacturing.
• Broad experience in equipment qualification, cleaning validation, process validation, computer systems, and devices.
• Proven experience presenting to Regulatory Agencies and managing quality/compliance issues.

Culture & Benefits

• Opportunity to launch a state-of-the-art, $2B greenfield facility from the ground up.
• Fast-paced, entrepreneurial environment with a high level of accountability.
• Discretionary annual bonus based on individual and company performance.
• Comprehensive corporate benefits package.
• Culture focused on Continuous Improvement and a Quality Mindset.