Automation Engineering Manager - Kindeva Drug Delivery/Summit Biosciences

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.

Description:

The Automation Engineering Manager is responsible for leading and managing process automation 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 and to manage related budgets and timelines.

Essential Duties:

• Lead projects 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 programs 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.
• Lead qualification activities to assure facilities, utilities and process equipment qualifications are performed to company standards.
• 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.
• Leads projects such as; new equipment design and procurement, implementation of automation, identification and installation of electronic management systems, etc.
• 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.
• Work on multiple validation projects simultaneously and coordinate test work.
• Write protocols for manufacturing, utility and lab equipment and processes.
• Plan, coordinate and track the progress of validation projects.
• Compile validation packages and ensure all required documentation is complete.
• Champion process improvement projects and ensure equipment and systems remain in a qualified state.
• Assure compliance with quality policies and procedures related to validation activities.
• Lead investigations related to validation deviations and ensure thoroughness of investigation, documentation and closure.
• Writing, review and approval of technical documents and reports such as protocols, SOPs, filing documentation and other cGMP documents.
• Ensure that engineering projects are properly planned, prioritized and managed to facilitate completion in accordance with facility goals and objectives.
• 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.
• Staff and develop team to consistently achieve and exceed objectives.
• Develop robust talent within a team for future growth.
• Develop and leverage product knowledge to help ensure customer needs are fulfilled by identifying and meeting all critical quality attributes.
• Develop and execute engineering strategic plan with key elements including capacity, business continuity, technology, profitability, asset utilization, etc.
• Help build a safety culture that strives for zero injuries through engagement and a focus on prevention and strong safety behaviors.
• Lead/support investigations and projects to improve quality, safety, customer service and other business needs.
• Plan revalidations/verifications together with the validation team, and assure the Validation Master Plan (VMP) is up to date
• Develop and improve preventive maintenance requirements for new and existing equipment

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
• Experienced user of automation and engineering software including: Cognex In-Sight, Cognex VisionView, RS Logix, 2D (AutoCAD or equivalent) and 3D (Autodesk Inventor or equivalent) design software
• Experienced with automation hardware including: PanelView and other user interfaces, industrial PCs, PLCs, power supplies, PID controllers, sensors, switches, servos, servo drives, conveyors, cameras, robots, and servers
• Experience working with mechanical, electrical, electromechanical, and pneumatic instruments/devices including pressure gauges, pressure sensors, RTDs, thermocouples, humidity instruments, chart recorders, relays, solenoid valves, pneumatic valves, pumps, heating elements, cylinders, linear actuators, and gear boxes
• Excellent knowledge of validation principles including commissioning, IQ/OQ/PQs, Process validation, cleaning validation, Computer Related Systems validation and serialization
• 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