Specialist - Engineering

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

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.

Position Description:

West Point Technical Services for the Polysaccharide Vaccine End to End is seeking a highly motivated individual to support a capital project technical transfer of a conjugate bulk vaccine manufacturing process to a new facility. In this role, the Specialist will work as an individual contributor in close collaboration with the project team to provide technical support for the qualification of the facility and equipment, assessment and implementation of manufacturing process improvements, and full scale development and demonstration.

Responsibilities include, but are not limited to:

• Technical ownership for a portion of the manufacturing process, supporting the design and qualification of the process and equipment.

• Managing all timelines (change control, technical documents, sub-projects) to ensure key master project due dates are met; escalating any potential misses and develop remediation plans when possible.

• Authoring Change Control documentation for complex process, validation, equipment, facility/utility and/or automation changes.

• Authoring technical protocols, applying studies and reporting results/conclusions in support of product tech transfer.

• Utilize sound engineering principles to support qualified validation processes as required per current Good Manufacturing Practices (cGMPs).

• Authoring Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures)

• Providing on-the-floor support of operational and technical issues; collaborating with the shop floor to aid in equipment, automation or process trouble shooting or to provide immediate responses to deviations and protocol exceptions

• Participating in FAT/SAT, equipment qualification, HAZOP, and Quality Risk Assessment

• Promote team safety, environmental, and compliance objectives.

• Collaborating effectively across the project team and PV Focus Factory (Quality, Operations, Mechanical Services, Automation, Outside Contractors, etc.)

Education Minimum Requirement:

• Bachelor's Degree in Chemical Engineering, or Biological Science or other appropriate science or engineering field.

Required Experience and Skills:

• Minimum of 1 year post-Bachelor’s degree experience in support of Production, Validation, Process Engineering, Technical Operations or related experience.

• Prior experience with bulk vaccine manufacturing.

• Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills.

• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.

• Demonstrates interpersonal, technical aptitude and problem-solving skills.

• Demonstrated ability to work both independently and as a part of a team.

• Familiarity with cGMPs, CFR, and other appropriate regulations in relation to vaccine manufacturing.

Preferred Experience and Skills:

• Strong technical problem-solving and troubleshooting abilities.

• Change Control and Project Management experience.

• Bulk Vaccine Technical Support experience.

• Experience with Trackwise, MIDAS, SAP, Delta V, MES.

• Experience with introduction of process changes to a licensed process.

Our Manufacturing & Supply Division is dedicated to be 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 …

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.

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.

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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Current Employees apply HERE

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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 Poster

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R161878