Lead Process Engineer (Supervisor) - Biotech Manufacturing

About the position

This position will lead a team of professionals and be responsible for the design, implementation, and troubleshooting of manufacturing processes, instrumentation, and equipment start-ups from the laboratory through manufacturing scale. This individual will work closely with stakeholders to provide coaching and direction for groups including: cell culture, fermentation, purification, engineering, design, validation, and scale-up. This Process Engineering team will be involved with projects supporting our GMP commercial biologics production suites including: capital improvements projects, equipment upgrades/installs, and resolving more complex deviations & corrective actions. Prior experience in Pharmaceutical or Life Science manufacturing facilities is preferred, or experience in related GMP manufacturing environment. This is an onsite based role Monday-Friday. Relocation assistance is eligible for selected candidate.

Responsibilities

• Hire, train, develop and coach team members
• Align individual performance expectations with organizational goals
• Develop performance goals collaboratively with direct reports
• Ensure that performance goals are clearly communicated and current
• Provide constructive and timely feedback towards performance expectations and goals
• Coaches team members and leads process and equipment troubleshooting to support deviations, corrective actions and related issues
• Technically independent and maintains up-to-date knowledge of relevant standards and regulatory compliance requirements and independently contributes to the development of the team
• Initiate and oversee projects, tracking spending of budgets, creating scope of work, justification, risk assessments, cost estimates, implementing purchase order requisitions, and controlling payment schedules
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
• Provide guidance on coordinating fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems, including documentation of IQ/OQ protocols, test executions, and summary reports
• Point person for process improvement activities, including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT and SAT protocols
• Contributes to long-term strategic development of engineering program and organizes the strategy into actionable deliverables for relevant engineering team
• Provides engineering input and direct support during audits and inspections, including presenting directly to auditor/inspectors
• Provides technical support to team, including troubleshooting equipment/process issues in commercial process as well as during new equipment implementation

Requirements

• Bachelor's degree in an engineering or technical discipline required
• Master's degree in engineering or related discipline preferred
• Bachelor's degree with a minimum of six (6) years' related experience required
• Master's degree with at least four (4) year's related experience preferred
• Previous supervisory experience (direct or indirect) or leadership development training preferred
• Knowledge of Automation, GMPs, Compliance, and Regulatory requirements is essential
• Excellent communication skills and ability to work in a high-paced team-oriented environment

Benefits

• Relocation assistance for selected candidate