Summit Biosciences is a specialized pharmaceutical company that develops, manufactures, and commercializes prescription nasal spray products. Summit Biosciences is experiencing significant growth and offers competitive compensation annual bonus, 401k plan, paid holidays, PTO, health/dental/vision/life insurance, short/long term-disability, an incredible collaborative and challenging culture in a team-oriented environment.

Summit Biosciences is an Equal Opportunity Employer. Summit Biosciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by applicable federal, state and local laws. All employment is decided on the basis of qualifications, merit, and business need.

Summary:

The Engineering Manager is responsible for leading and managing process design engineering, procurement and qualification activities for strategic capital, troubleshooting and operational improvement projects for the organization.

This position is also responsible for the development and / or technology transfer of new solutions and modifications to our existing manufacturing process automation systems to solve process problems, optimize equipment performance and reliability. The position will also manage related budgets and timelines.

Essential Duties:

• Lead the engineering team to plan, organize and manage activities to solve process & production problems, develop and implement process improvements, and implement new products into manufacturing while maintaining the highest quality standards and facilitating continuous improvement in product cost, asset utilization, cycle times and equipment reliability.
• Maximize the success rate for production operations by instituting equipment to minimize mechanical failure and procedural errors.
• Develop and lead strategic activities for process and plant improvements in order to increase efficiency and drive down costs.
• Lead the design of facilities and equipment and the optimization of existing manufacturing processes to deliver FDA compliant production capacity on time and within budget.
• Guide the specification and selection of manufacturing equipment/utility equipment and award architectural and engineering contracts based on comparative bids and analysis.
• Motivate, recruit and develop key employees. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
• Assist with planning and executing capital plan for facility and production equipment related spending to assure production is in a position to meet new product development and product launch manufacturing requirements.
• Responsible for understanding the process requirements and how they impact equipment design.
• Communicate with partners and clients in order to identify and implement any necessary equipment or capabilities for new projects.
• Champion process improvement projects and ensure equipment and systems remain in a qualified state.
• Writing, review and approval of technical documents and reports such as protocols, SOPs, filing documentation and other cGMP documents.
• Promote cooperation and teamwork with all departments by open, candid communication and timely coordination.
• Actively drive culture of ownership and engagement through effective goal alignment and establishment of clear expectations and accountability.
• Develop and leverage product knowledge to help ensure customer needs are fulfilled by identifying and meeting all critical quality attributes.
• Help build a safety culture that strives for zero injuries through engagement and a focus on prevention and strong safety behaviors.

Candidate Attributes

• Exceptional organizational skills and attention to detail
• Superior interpersonal and written communication skills and demonstrated ability to effectively communicate with all levels of the organization
• Extensive knowledge of cGMP regulations
• Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners
• Ability to clearly and concisely articulate constraints in a quantifiable manner and identify alternatives in order to keep projects on schedule
• Ability to influence and negotiate skillfully through tough situations while maintaining good will and important relationships
• Ability to work in a lean, action oriented organization and demonstrate a strong work ethic
• Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team
• Ability to inspire transformative thinking and motivate employees to deliver benchmark performance
• Ability to provide innovative, compliant ideas or alternatives that create value, including seeking new information and external insights
• Take ownership and be accountable for automated equipment design and optimal operation

Minimum Qualifications:

• BS in engineering or relevant technical discipline
• 10 years of experience in pharmaceutical engineering and validation related functions
• Experience managing plant design, construction, commissioning and validation projects
• Hands on experience in validation, mechanical/electrical equipment troubleshooting and repair, automation project management, automation control systems, PLC programming, wiring automation systems and vision systems is a plus.
• Excellent working knowledge of cGMPs, OSHA compliance, HVAC systems and cleanrooms, automated pharmaceutical processing and plant equipment
• Excellent technical writing, communication and organizational skills
• Experienced in financial and accounting principles/spreadsheets and Project Management
• Good interpersonal skills and the ability to work well in a team environment