Durham's Technology Operations Specialist

Our Engineers support BCG operations, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company lifesaving vaccines in bulk and finished forms.

Durham’s Technology Operations Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology process knowledge, post approval support, and post commercial process enhancements activities for pipeline vaccine programs. This is position will support vaccine Drug Substance and Process Support and Media areas within the facility. .

Off-shift and weekend coverage will be required based on business unit needs and specific assignments.

Responsibilities may include but are not limited to:

• Provide technical/team support and leadership for commercial technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. buffers, media and cleaning solutions.

• Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process
• Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related)

• Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments

• Author or approve Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines.

• Lead aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls

• Evaluate and develop innovative process technologies, continuous process improvements and post launch process enhancements

• Provide post approval support and subject matter expertise support to ongoing manufacturing activities., Management Mentorship Fiber Optics Commissioning Operating Expense Fiber Optic Cable Business Valuation Telecommunications Technical Training Transport Networks Engineering Drawings Technical Leadership Full Stack Development Artificial Intelligence Business Transformation Optical Transport Networks Wavelength-Division Multiplexing +0 Distribution Engineer Actalent

Raleigh, NC*On-Site, Quality Management Technical Projects Workflow Management Project Coordination Project Stakeholders Project Documentation Project Implementation Manufacturing Processes Engineering Design Process Building Information Modeling +0 Login | JoinContact

Biology Auditing Coaching Vaccines Timelines Energetic Operations Leadership Management Automation Mentorship Innovation Compassion Supply Chain Adaptability Communication Data Analysis Presentations Investigation Risk Analysis Collaboration Change Control Lean Six Sigma Process Design Pharmaceuticals SAP Applications Telephone Skills Component Design Biopharmaceuticals Project Management Lean Manufacturing Influencing Skills Strategic Planning Technical Services Regulatory Filings Process Validation Process Improvement Process Development Technology Transfer Contingent Workforce Process Optimization Chemical Engineering Deviation Management Regulatory Compliance Industrial Engineering Project Implementation Biological Engineering Change Control Process Technical Documentation Biochemical Engineering Process Implementations Deviation Investigations Change Control Management Interpersonal Communications Good Manufacturing Practices Troubleshooting (Problem Solving) Piping And Instrumentation Diagram Manufacturing Execution System (MES), * Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of two (2) years of relevant experience or a Master of Science Degree.

Required Experience and Skills:

• Experience in vaccine or biologics manufacturing within a cGMP environment

• Experience authoring technical documentation within a cGMP context

• Proven leader with influence and outstanding communication (written & presentation) skills

• Experience with project strategic plan development and management

• Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development

Preferred Experience and Skills:

• Experience in bulk upstream and/or downstream vaccine processes within a cGMP environment

• Experience in manufacturing support processes including media development/manufacture and/or single-use component design and qualification

• Experience with technology transfer methodologies for introduction/launch of a cGMP product

• Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply chain interruptions

• Authored complex process change control

• Authored complex deviation investigations

• Experience with validation documentation and execution

• Experience with SAP

• Experience with Manufacturing Execution Systems (MES)

• Experience with Delta V

• Ability to provide scientific mentorship and guidance to technical colleagues

• Ability to read Piping and Instrumentation Diagrams

• Lean Six Sigma belt certification

• Experience with process risk assessment tools

• Experience with responding to regulatory questions with multiple agencies (e.g.FDA, EMA)

• Experience with face to face presentation of technically complex subjects to regulatory inspectors

• Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time. #EBRG’s #VetJobs

Required Skills: Adaptability, Adaptability, Change Control Management, Change Control Processes, Change Controls, Chemical Engineering, Data Analysis, Deviation Investigations, Deviation Management, Equipment Troubleshooting, Good Manufacturing Practices (GMP), Lean Manufacturing, Legal Compliance, Manufacturing Execution Systems (MES), Manufacturing Systems, Personal Initiative, Process Design, Process Implementations, Process Improvements, Process Optimization, Process Verification, Professional Integrity, Project Implementations, Project Management, Regulatory Audits {+ 7 more}, AutoCAD Budgeting Visionary Scheduling Leadership Mentorship Innovation Voltage Drop Team Oriented Detail Oriented Problem Solving Design Analysis Microsoft Office Project Planning Electrical Codes Power Distribution Industry Standards Analytical Thinking Engineering Drawings Willingness To Learn Computer-Aided Design Distributed Computing Electrical Engineering Electric Power Systems Technical Documentation Engineering Design Process Verbal Communication Skills Electric Power Distribution Continuous Improvement Process +0 BIM / VDC Digital Delivery Actalent

Raleigh, NC*Remote

Planning Visionary Leadership Management Innovation Wastewater Coordinating Construction Communication Life Sciences Process Piping Pharmaceuticals Detail Oriented Problem Solving Clash Detection

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is $87,300.00 - $137,400.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.