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Engineering Manager

3 months ago

Lexington, United States Kindeva Drug Delivery Full time

Kindeva is a leading global contract developer and manufacturing organization (CDMO) with delivery platform experience expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. The Lexington location develops, manufactures, and commercializes prescription nasal spray products and is experiencing increasing continuous growth. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture more tomorrows.


Job 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 and optimize equipment performance and reliability. The position will also manage related budgets and timelines.


Compensation & Benefits:

This is a full-time position with a competitive salary and benefits package. Benefits include medical, dental, and vision insurance, 401K with company match, paid time off, and opportunities for career growth and development.


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 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 plans for facility and production equipment-related spending to ensure the manufacturing department meets 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 to identify and implement any necessary equipment or capabilities for new projects.
  • Champion process improvement projects and ensure equipment and systems remain qualified.
  • 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 through open, candid communication and timely coordination.
  • Actively drive a culture of ownership and engagement through effective goal alignment and establishment of clear expectations and accountability.
  • Develop and leverage product knowledge to help fulfill customer needs 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 communicate with all levels of the organization effectively
  • 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 to keep projects on schedule
  • Ability to influence and negotiate skillfully through tough situations while maintaining goodwill 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