Sr. Specialist, Engineering

Job Description

Key vaccine product franchises are experiencing significant growth requiring staffing to support key initiatives. The Sr. Specialist, Technical Services Process Engineering in the BioBacterial Manufacturing End-to-End is responsible for technical leadership and execution of projects in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture. In this role, the Sr Specialist will work as an individual contributor as well as a team or project lead to lead work of others as required. Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions.

Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments. Additional responsibilities include:
  • Responsible for defining and leading projects. Specifically, will use standard project management approaches and assemble and lead teams in the execution of projects with responsibility for resourcing, charter development, project planning and tracking, risk management, and escalation. The incumbent will operate with a high degree of independence, assuring alignment with appropriate functional leaders and stakeholders while advancing their assigned projects and initiatives. The incumbent will have interest and capability in rigorous scientific approaches, operational excellence methods, systems development and change execution management, and strong analytical, communication and interpersonal skills. Collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business requirements.
  • Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts.
  • Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
  • Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation.
  • Design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale; Provide technical support to manufacturing for complex problems and issues
  • Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
  • Develop and assures consistent application of standardized work, engineering, and process tools.
  • Problem-solving skills and a hands-on approach to problem-solving, with a bias toward going to see problems for oneself in the field
  • May serve as a technical reviewer/approver for process changes.
  • Support process improvement projects, complex manufacturing investigations, digital and data integrity initiatives for the project
  • Support regulatory inspections based requests


Position Qualifications :

Education Minimum Requirement:
  • Bachelor's Degree in Engineering or Science


Required Experience and Skills**:
  • Minimum 5 years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 4 years; PhD degree plus 1 years).
  • Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a maintenance, process or validation support role
  • Strong Technical knowledge of Fermentation Process and Equipments
  • Strong Understanding of Change Control. Minimum of 2 years of experience in Change Control.
  • Demonstrated strong technical writing skills
  • Deviation management experience. Minimum of 1 year of experience in Deviation Management.


Preferred Experience and Skills:
  • Advanced degree (M.S., Ph.D.) in science or engineering
  • Ability to maintain strong working relationships with technical, quality and operations leaders
  • Experience with equipment and automation troubleshooting.
  • Experience in Process monitoring and trending tools
  • DeltaV, GCM experience
  • Regulatory inspection presentation experience with external regulatory authority representatives.


Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are ...

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

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.

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.

Residents of Colorado

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R127148