Associate Specialist, Engineering

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.

We are seeking a Growth and Improvement minded Associate Vaccine Manufacturing Technical Support Specialist that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

​Summary, Focus and Purpose

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

The Associate Vaccine Manufacturing Technical Support Specialist will provide engineering technical support to the manufacture of liquid vaccines. The role is focused on technical services support with primary focus in the areas of customer complaints, and deviation investigations. The role also encompasses technical services support with primary focus in the areas of deviation management, validation and product franchise support. Specific assignments maybe focused in one area or span across multiple areas of focus.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Conducting customer complaint investigations, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment and where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.

• Providing on-the-floor support of operational and technical issues | Collaborating with the shop floor to provide immediate responses to deviations and potential deviations

• Conducting real time investigations with the goal of fully understanding root cause and product impact within five days of event discovery

• Conducting deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment and where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.

• Completing projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and continuous improvement projects that seek to improve yield, reduce cost, or lower our processing cycle times

• Preparing source documentation for regulatory filings, supporting requests for regulatory inspections related to process overviews, investigations, projects and validation

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

• Supporting team safety, environmental and compliance objectives

• Managing investigation, project and validation study timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible

• Collaborating effectively with the area Coaches, Operators/Mechanics, support groups (Maintenance, Automation, Technology, Quality, and Planning)

• Executing projects and assigned studies in a right-first-time manner

• Actively using and championing the use of Lean Six Sigma (LSS) and Company Production System (CPS) tools, both in problem solving and day-to-day operational activities

Education

• B.S. or B.A. in Mechanical or Chemical Engineering degree or other science degree

Experience | Skill | Knowledge

Required

• Engineering or science educational background

• Principled verbal and written communications

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

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

Preferred

• Six plus months of relevant work experience

• Support of vaccine operations or technical services support

• Experience with troubleshooting biotech equipment and closed system processing

• Experience with Trackwise, MIDAS, SAP

• Ability to read Piping and Instrumentation Diagrams

• Support of deviation investigations and/or project work

• LSS/MPS certification/experience

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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.

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.

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

Secondary Language(s) Job Description

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R242996