Senior Specialist - Technical Operations

Job Description

We currently have a Senior Specialist of Engineering position available in Technical Operations with process subject matter expertise required within our company's product technical operations team. The position will require SME level expertise in applicable protein chemistry with the expectation to be able to discern the multi-variant relationship between the purification process and product attributes at all steps within the process. The position will interface with our company product's product leaders, our company's product process development, and other product / process scientists within our Company. The position will involve predictive process monitoring as well as investigation of complex process deviations.

The successful candidate will have the opportunity to apply their enthusiasm, technical skills, and leadership skills as a member of a multidisciplinary team supporting vaccine manufacturing. 

Assignment expectations include:

• Achieve Safety, Quality, and Environmental compliance excellence in all assignments

• Rigorous adherence to tier and IPT standard work

• execute on service level agreement expectations for the role

• Provide subject matter expert level leadership, coaching, and mentorship of tech ops and cross functional stake-holders

• Serve on the IPT specific tech ops leadership staff and contribute to organizational success by improving business processes and approaches. Expected to lead SME related initiatives

• Provide subject matter expert level leadership, coaching, teaching, and mentorship of tech ops and cross functional stake-holders. Work to develop future SMEs

• Manage portfolio of relevant area initiatives, prioritizing with cross-functional peers.

• Lead multidisciplinary teams within or across functional areas

• Develop SME level knowledge down to the unit operation level manufacturing process (process flow, CPPs, CQA, KOPs, KPA, device / equipment level). Should have SME level competency with DeltaV process interaction

• Lead and conduct technical investigations (including complex / significant) and analyses, recommending corrective actions, and seeing them through to successful, sustainable implementation

• Review and approve  technical investigations. Teach and coach technical investigation skills (root cause, writing, and presenting).

• Develop change owner / task capability for Veeva and IPI level changes. Execute on change task responsibilities. When acting as change team member, develop SME level capability navigating change systems, cross-site change strategies, collaborating / aligning with multidisciplinary teams (CMC, etc.)

• Write, review, approve documentation for technical and regulatory compliance excellence

• Act as the primary regulatory inspection contact for the SME scope. Expected to interact directly with inspectors and contribute to effort to develop / author observation responses.

• required to be available for off-hours / extended hours work to include (but not limited to) execution of specific activities (batch troubleshooting, validation, process simulation, project execution), escalation and decision making of critical topics (safety, environment, asset, batch quality), regulatory inspections, and event level circumstances

Education Minimum Requirement:

• B.S. degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with four (4) years of relevant industrial experience. OR

• M.S. degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with two (2) years of relevant industrial experience. OR

• Ph.D. in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with one (1) year of relevant industrial experience

Required Experience and Skills:

• Demonstrated subject matter level knowledge of our product's process and product attributes

• Minimum of two years of experience in sterile manufacturing

• Experience with direct or indirect interaction with regulatory authorities

• Has independently authored and lead efforts to complete investigation level deviations

• Demonstrated ability to lead people via influence as opposed to formal reporting structures

• Demonstrated success in managing and delivering multiple