Senior Specialist, Engineering

Job Description

Position Description

The Senior Specialist, Technical Services Process Engineering in the BioBacterial Manufacturing End-to-End is responsible for technical leadership and execution of projects in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture.  In this role, the Sr Specialist will work as an individual contributor as well as a team or project lead to lead work of others as required.   Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions.    Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments.

Additional responsibilities include:

• Responsible for defining and leading equipment based projects, including the remediation of obsolescent parts, vendor communication, and IOQ activities.  

• Specifically, the engineer will use standard project management approaches and assemble and lead teams in the execution of projects with responsibility for resourcing, charter development, project planning and tracking, risk management, and escalation. 

• The incumbent will operate with a high degree of independence, assuring alignment with appropriate functional leaders and stakeholders while advancing their assigned projects and initiatives.

• The incumbent will have interest and capability in rigorous scientific approaches, operational excellence methods, systems development and change execution management, and strong analytical, communication and interpersonal skills. 

• Collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business requirements.

• Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts.

• Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.

• Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation.

• Design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale;  Provide technical support to manufacturing for complex problems and issues

• Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.

• Develop and assures consistent application of standardized work, engineering, and process tools.

• Problem-solving skills and a hands-on approach to problem-solving, with a bias toward going to see problems for oneself in the field

• May serve as a technical reviewer/approver for process changes.

• Support process improvement projects, complex manufacturing investigations, digital and data integrity initiatives for the project

• Support regulatory inspections based requests

Education Minimum Requirement:

• Bachelor's Degree in Engineering or Science

Required Experience and Skills:

• Minimum 5 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 4 years; PhD degree plus 1 years).

• Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a maintenance, process or validation support role

• Minimum of 3 yrs deviation management experience in qualified production facilities

• Strong Understanding of Change Control. Minimum of 2 years of experience in Change Control.

Preferred Experience and Skills:

• Advanced degree (M.S., Ph.D.) in science or engineering

• Ability to maintain strong working relationships with technical, quality and operations leaders

• Experience with equipment and automation troubleshooting.

• Experience in Process monitoring and trending tools

• DeltaV, GCM experience

• Regulatory inspection presentation experience with external regulatory authority representatives.

• Experien