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Merck & Co, Inc

Senior Specialist, Engineering ( MERCUSR114215ENUS)

Engineering and Architecture

Architectural Engineering

Yearly

No

West Point, Pennsylvania, United States

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.

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 Senior Specialist will work as an individual contributor in close collaboration with the project team to support qualification of the facility and equipment, assess and implement manufacturing process improvements, and support full scale development and demonstration as the technical expert.

Responsibilities

  • Technical ownership / subject matter expert for portion of the manufacturing process, providing technical support for complex problems and issues including process/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 new or updates to 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

  • Promoting 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 Requirement

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

Experience and Skills

Required

  • Minimum of 3-5 years post-Bachelor degree experience in support of Production, Validation, Process Engineering, Technical Operations

  • Bulk vaccine manufacturing

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

  • Ability to work in fast-paced, complex environments and escalate appropriately

  • Interpersonal, technical aptitude and problem-solving skills

  • 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

  • Strong technical problem-solving and troubleshooting abilities

  • Change Control and Project Management

  • Bulk Vaccine Technical Support

  • Tackwise, MIDAS, SAP, Delta V

  • Introduction of process changes to a licensed process

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. 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

EEOC GINA Supplement​

OFCCP EEO Supplement

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:

Domestic

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R114215