Engineering leadership position for degreed Engineer/Manager with experience in pharmaceutical operations and knowledge of facility equipment/utilities. Position has responsibility for supervising/directing internal engineering resources, as well as contract service providers, to ensure business objectives are met and site facilities, utilities and equipment meet business requirements in a safe and compliant manner. 

*KEY DUTIES: *

• Ensure engineering department resources are responsive and effective in meeting the tactical and strategic needs of the site. 
• Development and implementation of process and reliability improvement projects. 
• Provide oversight to relationships with key vendors, A&E firms and engineering service providers. 
• Ensure good project management practices are applied within department. 
• Assist maintenance and manufacturing with systems operation, preventive maintenance, and specification and procurement of replacement equipment, spare parts and maintenance supplies.
• Engage with customers to ensure a high level of customer service.
• Ensure interdepartmental teamwork to meet site objectives. 
• Develop staff with technological understanding, cross training and problem-solving techniques, to meet new business objectives and maximize team flexibility/capability.
• Provide coaching/feedback to develop/enhance personnel capabilities.
• Set and communicate clear standards/expectations of performance within the group.
• Remain current on industry and engineering standards and trends.
• Ensure that activities meet all regulatory standards.  (e.g. FDA, MHRA, OSHA, EPA)
• Monitor facility/utility overall operational robustness. Identify, develop scope and estimates, and manage projects to completion for system improvements and operational excellence (OE) activities. 
• Assist MFG, RS and ES groups with deviations/investigations.
• Oversee the development of Standard Operating Procedures for equipment and systems throughout the facility.
• Write, review and approve design documents.  Review and approve C&Q documents. 
• Develop, conduct and document test methods for utility systems troubleshooting, commissioning and validation.
• Participates in developing and integrating new technology/manufacturing innovations/new products that support the strategic goals of the business.

SKILLS/ABILITIES: 

Thorough mechanical and chemical engineering knowledge as it applies to general facility systems and equipment, and drug product facility systems and equipment.

Thorough knowledge of electrical, electronic and instrumentation systems.

Thorough knowledge of computer systems operation and software.

In-depth knowledge of CGMP, OSHA, EPA and FDA facility requirements and regulations.

General knowledge of chemistry, statistics, facility design, cost estimation, process control and process scale-up.

General knowledge of pharmaceutical operations and equipment validations.

Ability to specify and size equipment systems and process equipment.

Excellent communication and documentation skills.

"Hands-on" ability to troubleshoot and install equipment.

Ability to troubleshoot and maintain facility/utility equipment and processes.

Excellent people skills to supervise personnel and interact with other facility and research groups.

Excellent writing skills to prepare engineering and validation protocols, facility reports, summary documents, equipment specifications and SOPS.

In-depth knowledge of internal change control and documentation control.

Assists Department to maintain effective operations.

Leads the development of area goals and objectives. Manages implementation o