Senior Specialist, Validation Engineering

Job Description

Our Engineers support internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biologics, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Position Description:

GENERAL INFORMATION

A Senior Engineer will provide organizational support and technical leadership for the Teknika manufacturing area in Durham, NC. The Validation group at Teknika is a group comprised of 6 scientists and engineers and must demonstrate strong technical and project management skills. The individual must embrace an empowered team culture.

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

POSITION OVERVIEW

The successful candidate will be energetic and technically sound, with strong interpersonal, communication, and collaboration skills responsible for supporting PQ and requalification activities for multiple pieces of equipment. The Senior Specialist will primarily support vaccine drug manufacturing via Validation program execution and partnering with cross-functional teams (i.e. Maintenance, Quality, and Operations) for continued process manufacturing.

Additionally, this role will contribute to the performance and results of a department, provide validation guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Off-shift and weekend coverage will be required at times based on business unit needs and specific assignments.

Specific assignments may be focused in one area or span across multiple areas of focus.

Responsibilities may include but are not limited to:

• Partner with Teknika Technology, Operations, Quality and Maintenance teams to deliver tactical and strategic projects as needed.

• Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process.

• Lead validation studies and author the associated documentation

• Participate in the equipment specification, selection/procurement, and qualification phases of vaccine capital projects

• Collaborate with internal/external partners, e.g. Other Company sites, Procurement, Raw Material & Component Suppliers

• Author, review, and/or edit validation documents to support regulatory filings

• Support Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes.

• Lead validation topics in regulatory inspections by presenting and defending validation documentation.

• Develop technical and manufacturing documents necessary for development studies, cleaning, sanitization, depyrogenation and sterilization process validation.

• May be responsible for leading teams of contractors to efficiently accomplish project goals.

• Provide technical support to help develop and execute project plans; and obtain and analyze relevant data and prepare appropriate reports for regulatory submissions. 

• Design validation studies, author and approve protocols, and ensure alignment with corporate standards and site guidance for validation.

• Serve as mentor for less experienced teammates, assisting with technical development.

• Author or update Validation SOPs

• Assist with troubleshooting and effectively resolving problems. Develop and implement corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply and prevent recurrence. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve it at root cause.  

• Maintain alignment with internal Technical personnel regarding validation practices for products, processes and equipment.

• Partner with Operations, Quality, and Automation functional areas on validation study implementation.

Position Qualifications:

Education Minimum Requirement:

• Bachelor of Science Degree in Engineering or Life Sciences with a minimum of five (5) years of relevant experience;

• or a Master of Science Degree with a minimum of three (3) years of relevant experience;