Manager, Process Engineering

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
This individual is responsible for communicating company goals, safety practices, and deadlines with dedicated Engineering teams. They are responsible for motivating team members, including indirect reports and assessing performance and evaluation.
ROLE RESPONSIBILITIES
Essential Duties:
• Manage the day-to-day issues with the Process Development Engineering team.
• Mentor the newer members of the Process Development Engineering team.
• Develop/continuously improve a training and onboarding plan for new members of the Process Development Engineering team.
• Work in a safe manner in accordance with site procedures.
• Identify and lead implementation of procedural improvements.
• Oversee group adherence to orderly standards in accordance with SOPs.
• Oversee equipment readiness and acquisition including and ensuring adherence to FDA guidance and cGMP principles as appropriate.
• Identify new procedures, write, revise, review, and approve SOPs, Batch Records, Forms, Protocols and Reports.
• Support process implementing statistical design of experiments software to design and analyze processes.
• Ability to leverage regulatory requirements to drive projects through the product development process.
• Excellent oral and written communication skills required to facilitate new product development
• Utilize investigative skills for aberrant deviation investigations.
• Other duties as assigned.
Knowledge Skills and Abilities:
• In-depth knowledge of performance metrics to identify operational constraints.
• Experience organizing training programs and listening to teammates.
• Ability to make decisions, delegate, and redelegate
• Sense of ownership and pride in group performance and its impact on the company’s success
• Strong critical thinking, problem solving, and time management skills.
• Ability to lead the group through process development engineering tasks with a risk-based, documented process to make decisions and complete development in a timely manner.
• Current knowledge in current pharmaceutical regulatory requirements for process development engineering.
BASIC QUALIFICATIONS
• Relevant Technical Degree (Master’s Degree preferred)
• Leadership Training
• Experience in FDA regulated environment (8+ years)


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