Quality Engineer, Lead (QS&C)

Technical Skills, Knowledge, and Experience

• Act as the Quality Engineering lead for the Sanford site, owning priorities and outcomes and establishing clear standards, workflows, and governance to ensure consistency and sustainability as the site grows.
• Lead and provide Quality oversight of GMP readiness activities for facility startup, including equipment, utilities, facilities, and process validation and documentation generation.
• Sustain compliance through lifecycle management of FUME systems, continuous improvement, and ongoing inspection readiness; confirm readiness of systems by reviewing evidence such as drawings, P&IDs, validation deliverables, and turnover packages to ensure fitness for intended use.
• Drive structured problem solving for issues related to equipment, utilities, facilities, instruments, PMs, and calibrations and contribute to the creation of the Preventative Maintenance (PM) and calibration programs, including review of plans, intervals, and criticality assessments.
• Execute and/or provide quality technical leadership of change controls and risk assessments (e.g., FMEA, hazard analysis), including defining risk strategy, ensuring appropriate mitigation, and approving risk acceptance decisions of FUME systems.
• Drive structure problem-solving for issues related to equipment, utilities, facilities, calibrations, and PMs and ensure all activities are consistent with data integrity expectations, Part 11 requirements, and ALCOA++ principles.
• Partner with Engineering, Validation, and Maintenance Teams to maintain inspection-ready documentation and asset status and work collaboratively across teams to support startup activities and ensure compliant execution.
• Review and approve work orders, CQV protocols and reports, change controls, deviations and CAPAs associated with FUME systems, and serve as the Quality lead for FUME related internal, external, and regulatory audits, including inspection preparation, execution, and follow-up.

Non-Technical Skills

• Results-oriented and able to navigate ambiguity. Demonstrates the ability to set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives.
• Adapts to change with clarity, patience, and understanding while influencing peers and key stakeholders through evolving challenges.
• Exhibits strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.
• Communicates with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness.
• Embraces personal growth through continuous learning and knowledge sharing, maintaining a growth mindset.
• Promotes inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.
• Contributes positively by recognizing achievements and encouraging a healthy work-life balance.
• Collaborates with respect, integrity, and humility, prioritizing collective success over individual gain.
• Resourceful and proactive, challenges the status quo, drives innovation, and develops creative solutions.
• Applies an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.

Job Requirements

• Education: Bachelor’s degree in engineering or science related field required. Master’s degree in engineering or science related field considered a plus.
• Experience: Minimum 8 plus years of direct industry experience in a GxP-regulated environment with a focus on Quality Engineering; including demonstrated experience serving as a Quality SME during regulatory inspections and/or audits.
• Experience: Demonstrated experience in qualification, validation, change control, and Quality Engineering activities.
• Experience: Direct experience with PM and Calibration systems, equipment lifecycle management, or CMMS platforms highly preferred.
• Experience: Familiarity with DS single-use biologics operations or greenfield startup environments is preferred.
• Other: Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.