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Job Details

Merck & Co, Inc

Specialist, West Point Technical Operations, Biological Bacterial Manufacturing (BBM) Projects


Security Operations


West Point, Pennsylvania, United States

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 Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Key vaccine product franchises are experiencing significant growth requiring staffing to support key initiatives. The Specialist, Technical Services Process Engineering in the BioBacterial Manufacturing (BBM) 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 Specialist will work as an individual contributor as well as a team or project lead 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.

Position Responsibilities:

  • Develop and execute Change Control inclusive of change definition, quality risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings. Lead change requests in order to achieve BBM strategic goals, enable continuous vaccine supply, and provide process robustness.

  • Ensure use of standard project management approaches and assemble, lead, or participate in teams for the execution of projects with responsibility for project planning, deliverables tracking, risk management, and escalation.

  • Operate with some degree of independence, ensuring alignment with appropriate functional leaders and stakeholders while advancing their assigned projects and initiatives.

  • Utilize automated control systems and data trending tools for troubleshooting and process monitoring.

  • Collaborate and engage with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, to author CRs, and local procedures as needed, to meet cGMP and business requirements.

  • Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation.

  • Execute projects in a right first-time manner against critical path timelines.

  • Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments

Education Minimum Requirement:

  • B.S. or M.S. in Chemical Engineering, Chemistry, Biology, Biochemistry or comparable discipline

Required Experience and Skills:

  • Minimum 2 years post-B.S. degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 1 years)

  • Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a maintenance, process or validation support role

  • Experience with executing projects in a classified, GMP operational production facility

Preferred Experience and Skills:

  • Strong understanding of Change Control and cGMPs

  • Experience with bulk and formulation/filling processes

  • Ability to foster and maintain strong working relationships with technical, quality, and operations leads.

  • Experience with equipment and automation control systems, troubleshooting, and data trending tools (DeltaV)

  • Experience with SAP and/or submitting BOM/DIR/Master Data changes.

  • Experience with document repositories (e.g. Trackwise, VeevaVault)

  • Strong analytical, communication and interpersonal skills

  • Interest and capability in rigorous scientific approaches, operational excellence methods, systems development and change execution management

  • Ability to design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.

  • Ability to develop and ensures consistent application of standardized work, engineering, and process tools.

  • Regulatory inspection presentation experience with external regulatory authority representatives

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 …

We are known as Merck & Co., Inc., Rahway, 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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today


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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

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.

Residents of Colorado:

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Search Firm Representatives Please Read Carefully
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.

Employee Status:



No relocation

VISA Sponsorship:


Travel Requirements:


Flexible Work Arrangements:



1st - Day

Valid Driving License:


Hazardous Material(s):


Requisition ID:R230873