Manager, Process Engineering

LifeNet Health•Virginia Beach, VA

18d•Onsite

About The Position

Every day, YOU help us to save lives, restore health, and bring hope to patients and families around the world. At LifeNet Health, we cultivate growth, innovation, and collaboration, where your contributions drive solutions that benefit humanity. Together, we are united by a mission greater than ourselves, a purpose rooted in healing. The Manager, Process Engineering is responsible for management of tissue process design, validation, implementation and improvements in accordance with applicable regulatory requirements. Ensure all activities are compliant with FDA regulations, ISO regulations, and AATB standards. Provides leadership and mentoring to the Engineering staff. This position will require strong analytical skills and a systems approach to problem solving. They must embrace Lean concepts, drive continuous improvements, commit to regular reduction of costs, and ensure the development of lean systems and procedures. Your work will have purpose every single day, contributing directly to life-changing outcomes.

Requirements

Bachelor’s degree in Engineering or a related technical field
Five (5) years of relevant Engineering experience
Three (3) years of progressively responsible leadership and management experience with demonstrated success in a highly complex organization.
Three (3) years of project management experience within a regulated environment.
Actively engages in talent management practices (selection, promotion, development, and engagement) to cultivate a workforce that is well aligned with current and emerging talent needs.
Builds and sustains partnerships across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes.
Written, verbal and presentation communication skills; ability to engage, inspire and influence people.
Proficient in Microsoft Office and in Project Management Software (e.g., MS Project).
Ability to plan, implement and monitor assignments effectively to meet the needs of the business.
Ability to use time in an effective and productive manner with ability to work under pressure with tight timelines, make critical decisions and maintain a sense of focus and urgency.
Demonstrates the ability to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends.

Nice To Haves

Bachelor’s degree in Engineering
Master’s degree in Engineering or Business Management
Three (3) years of Process Engineering experience in Medical Device, Pharmaceutical, or Biomanufacturing industries.
Certified Associate in Project Management (CAPM) or Project Management Professional (PMP)

Responsibilities

Provides leadership to assigned team by leading, guiding, and directing employees to be effective team members.
Ensures staff are equipped with the skills, tools, and talents necessary to perform their duties.
Utilizes established people processes (performance, development, succession, and career) to ensure team capabilities meet current and future organizational needs.
Leads teams to execute the transfer of new processes and products from Product Development to Production and Logistics.
Ensures effective technical training of production staff.
Develops, reviews, provides feedback on, and approves process validation protocols in alignment with regulatory principles.
Leads staff in executing projects of varying scope and complexity, including multi-department initiatives focused on process and equipment improvement.
Ensures alignment with LifeNet Health standards and applicable regulatory requirements.
Monitors and reports key performance indicators and objectives to support continuous improvement and timely completion of tasks and projects.
Contributes to department goal-setting and maintains costs within approved budgets.
Writes and revises material and equipment specifications.
Develops and updates SOPs and Work Instructions as required.