Sr. Princ. Process Engineer – DP Aseptic Biotherapeutic Automated Optical Inspection Equipment

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As part of the Global Process Engineering team the Sr. Princ. Process Engineer serves as the recognized technical authority and Subject Matter Expert for manual and automated inspection equipment. This role is accountable for the endtoend (E2E) process engineering ownership of manual and automated inspection equipment from conceptual design commissioning and qualification and initial equipment start-up for commercial manufacturing.

This role will be responsible for demonstrating their scientific technical and business expertise to develop the process/equipment solve sophisticated equipment issues optimize the process lead commissioning and qualification activities and line startup and ensure compliance to regulatory standards.

Key Responsibilities:

• Act as the senior technical leader and Optical Inspection (OI) equipment owner providing direction and oversight to internal teams and external partners (A&E firms construction contractors system integrators and equipment vendors) to define scope set expectations and execute project strategies.

• Demonstrated deep background and handson expertise in optical inspection technologies processes and equipment within a cGMP aseptic largemolecule biotherapeutic drug product environment.

• Proven track record in leading the design development and implementation of manual and automated optical inspection processes and equipment including recipe development and test kit design supporting large-molecule biotherapeutic aseptic drug products.

• Strong capability to develop and deliver automated inspection equipment specifications and engineering documentation including User Requirements Specifications (URS) data sheets technical specifications P&IDs and PFDs aligned with aseptic processing and sterile manufacturing requirements.

• Accountable for vendor evaluation and selection including assessing vendor capabilities reviewing bid packages and ensuring performance expectations are met through project.

• Demonstrated leadership in factory and site acceptance testing (FAT/SAT) commissioning qualification (C&Q) and startup ensuring systems are inspectionready and compliant with regulatory requirements.

• Ability to resolve complex technical issues during design installation and C&Q phases applying strong problemsolving skills and sound engineering judgment on OI equipment.

• Experience leading crossfunctional collaboration with Manufacturing MSAT Quality Facilities E&PS Procurement EHS and external partners acting as the primary technical authority for the OI equipment.

• Solid understanding of EHSbydesign principles construction safety requirements and project execution processes in cGMP environments.

• Ability to apply datadriven insights industry benchmarking and technology trends to influence design decisions and continuously improve inspection system performance.

• Demonstrated leadership skills to mentor influence and guide diverse and multicultural teams ensuring technical knowledge is maintained and expanded across the organization.

Qualifications

Education:

• Minimum of a Bachelors Degree in engineering required (Mechanical Engineering preferred) MS or MBA preferred.

Experience and Skills:

Required:

• Minimum of 10 years optical inspection process engineering and/or capital project execution experience within a large-molecule biotherapeutic cGMP environment.

• Strong background in aseptic large-molecule biotherapeutic drug product optical inspection principles

• Experience leading optical inspection process engineering activities across the full project lifecycle preferably within a capital project execution environment.

• Proven track record of developing and sustaining strong partnerships with key stakeholders serving as a trusted technical authority across Engineering Manufacturing MSAT Quality Facilities E&PS Procurement EHS and project leadership.

• Demonstrated ability to lead influence and motivate multicultural and geographically dispersed teams including internal teams and external partners within a matrixed capital project environment.

• Extensive experience interacting with external partners (A&E firms construction contractors system integrators and equipment vendors) to define technical requirements develop execution strategies and deliver project objectives as the Optical Inspection (OI) Subject Mater Expert and technical lead.

• Strong problemsolving and conflictresolution skills with the ability to address technical schedule and stakeholder challenges using sound engineering judgment and riskbased decision making.

• Deep understanding of complex technical and regulatory requirements impacting cGMP facility and equipment design with the ability to translate regulatory expectations into compliant practical and scalable system solutions.

• Demonstrated familiarity with technology advancements in vial cartridge and syringe container closure systems particularly as applied to sterile injectable biotherapeutic drug products.

Solid Understanding of the Following:

• cGMP requirements for optical inspection (manual and automated) in aseptic largemolecule biotherapeutic drug product commercial manufacturing.

• EHS requirements with a strong focus on EHSbydesign principles and construction safety throughout capital project execution.

• Startup commissioning and qualification (C&Q) processes for automated optical inspection equipment including system readiness and inspection performance verification.

• Engineering design principles for biotherapeutic drug products including aseptic processing sterile manufacturing optical inspection and regulatory compliance considerations.

• Construction and procurement processes including vendor management equipment procurement and contract execution within capital projects.

• Project controls and project scheduling methodologies with the ability to support integrated project plans and milestone-driven execution.

• Strong technical process engineering expertise coupled with a demonstrated passion for solving highly complex highimpact technical challenges.

• Excellent problemsolving communication and decisionmaking skills enabling effective leadership in a fastpaced evolving business and project environment.

• Proven ability to drive process engineering innovation for equipment and facilities ensuring technical knowledge is sustained expanded and embedded across the organization.

Preferred:

• Consistent track record leading largescale capital projects for optical inspection equipment with total project values in the range of $20M$100M.

• Experience supporting greenfield and/or brownfield cGMP drug product manufacturing facility startup in the area of optical inspection (manual and automated).

• Experience transitioning OI equipment from conceptual design through operational readiness in a commercial biotherapeutic drug product environment.

Other:

• This position will be located in Wilson North Carolina and will require full time on-site support. However the design of the facility will occur at an Engineering firm with frequent travel (> 75%) required until the project shifts to the plant site of Wilson NC.

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