Director Engineering & Facilities

SUMMARY:

The Director of Engineering and Facilities is responsible for the building, equipment and system performance of a cGMP manufacturing facility. The director leads, manages, and coaches engineering, maintenance, and capital project staff to ensure equipment and systems are designed, installed, and consistently perform as intended when needed. The director develops an engaged, high performing team that demonstrates Pegasus Labs' core values with a culture of safety and quality.

RESPONSIBILITIES:

• Develop and implement short- and long-term strategic plans to ensure manufacturing processes and manufacturing equipment are in place and meet business objectives.
• Work cross-functionally to ensure effective manufacturing processes, and product transitions. Lead and execute continuous improvement initiatives to expectation, meeting quality, cost, and supply chain objectives, and standards.
• Develop, implement, train, and monitor the effectiveness of engineering systems and procedures to ensure compliance with FDA, GMP and all other applicable agency regulations.
• Lead and execute validations for new equipment, equipment improvement, and process improvements. Oversee corrective and preventative maintenance and repair of facilities, utilities, and equipment.
• Develop formal project plans to include the proposed technical approach, budget, and key milestone completion dates for all assigned projects, and prepare high level technical reports, analysis, recommendations, and presentations reflecting the project status and results.
• Prepare departmental budgets and control expenditures to stay within spending limits.
• Anticipate and resolve the highest-level issues and conflicts that could impact operations success and maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Represents Facilities and Engineer Department during client audits, regulatory inspections, and business development activities when applicable.
• All other tasks as requested or assigned.

QUALIFICATIONS AND REQUIREMENTS:

• Bachelor's degree in electrical, mechanical, or chemical engineering. Advanced degree preferred.
• 8+ years of progressive experience in high-volume, multi-product pharmaceutical or related manufacturing facility.
• 5+ years of management experience leading a successful team (direct reports or projects).
• Demonstrated experience leading and implementing lean manufacturing/Six Sigma initiatives.
• Management of manufacturing and facilities equipment repair/preventative maintenance programs as well as TPM program implementation.
• Experience in new GMP site startup, GMP commissioning and GMP validation. Comprehensive understanding and experience in startup, shutdown and maintenance of ISO 8 cleanroom facilities.
• Knowledge of FDA, GMP, and ISO regulations and standards.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization, including interpersonal and presentation skills.
• Data analysis skills, able to identify the required data, gather and analyze to draw conclusions and support project objectives or root cause analysis. Capable of communicating large complex technical problems to non-technical audiences.
• Significant experience in identifying and driving organizational change and operational excellence preferred.
• Proficient with Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
• Proficient with AutoCAD and MathWorks.
• Proficient with Quality Management Systems (i.e., Empower, Master Control).
• Travel up to 25%.