Senior Specialist - Engineering

Job Description

Our Engineers ensure that 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:

This position will support the Live Virus Vaccine End-To-End Business Unit as part of the Technical Operations Strategic Projects Team. The Senior Specialist is accountable for:

• Providing technical assistance to the Live Virus Vaccine manufacturing areas

• Implementing continuous improvement projects and sponsoring process and equipment investigations

• Perform work as an individual contributor, team member, mentor, and project manager.

• Completes and/or directs projects to improve the performance of our processes, including: value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times; projects aimed at improving Right[1]First-Time performance or preventing/reducing deviations; and investigation Corrective/Preventative Actions (CAPAs).

• Meets team safety, environmental, and compliance objectives. Manages project and investigation timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.

• Authors, updates, and/or reviews and approves technical and manufacturing documents necessary for engineering studies, change control.

• Provides advanced technical assistance to manufacturing for complex problems and issues including process/equipment.

• Partners effectively with the area Coaches, Operators/Mechanics, assist groups, Quality, Planning, project teams, and external component and equipment vendors.

Education Minimum Requirement:

• Bachelor degree in Chemical Engineering, or Biological Science or other appropriate science or engineering field

Required Experience and Skills:

• Minimum of 3-5 years post-Bachelor degree experience in support of GMP manufacturing operations (Production, Validation, Process Engineering, Technical Operations, etc.)

• Leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills

• Strong technical problem-solving and troubleshooting abilities

• Ability to work both independently and as a part of a Team

• Ability to maintain strong working relationships with technical, quality and operations leaders

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

• Executes, and/or directs continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.

• Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best comprehend and resolve the root cause.

• Designs, conducts, and/or reviews and approves experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.

• Sponsors regulatory inspection activities for the facility Provides on-the-floor management of complex operational and technical (process/equipment) issues.

Preferred Experience and Skills:

• Strong understanding of Change Control

• Minimum of two years of experience in Change Control

• Minimum three years project management with project implementation in qualified production facilities

• Experience managing direct reports or mentoring colleagues

• Drug Substance or Drug Product Vaccine Technical Support or development experience

• Experience with Process Performance Qualification

• Introduction of process changes to a licensed process

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

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., 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. 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.

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 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:R115397