Engineering Manager

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 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 that the manufacturing department can 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 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 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