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Senior Specialist, Technical Engineering

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse 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.  Due to the importance of this facility in our Company Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people.

Durham’s Technology Transfer Senior Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology transfer process knowledge, post approval support, and post commercial process enhancements activities for pipeline vaccine programs.  This is position will support vaccine drug substance site readiness and technology transfer focusing on either upstream, downstream, and/or culture media/support systems.

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

  • Lead technical studies and author documentation associated with site commercialization efforts

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

  • Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related)

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

  • Develop effective data analytics methodologies, including statistical process control, deepening process understanding

  • 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.

Education Minimum Requirement:

  • Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of five (5) years of relevant experience; a Master of Science Degree with a minimum of three (3) years of relevant experience; or a Ph.D. with relevant academic experience.

Required Experience and Skills:

  • Travel: 25% of the time

  • 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 with Clean-in-Place systems

  • 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. 

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

If you need an accommodation for the application process please email us at staffingaadar@merck.com

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster
EEOC GINA Supplement​
OFCCP EEO Supplement

OFCCP Pay Transparency Rule


We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

IPA, NaOH, Ethanol, other chromatography regeneration solutions, typical GMP cleaning agents

Number of Openings:

1

Requisition ID:R7951

Senior Specialist, Technical Engineering

Durham, NC
Full Time

Published on 10/04/2019