Technical Operations Engineering Specialist

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 Technical Operations Engineering 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

We are searching for a highly motivated individual to provide engineering technical support for a vaccine manufacturing facility. The primary focus of the role is customer complaint investigation with a secondary focus in deviation management and includes investigation of customer complaints, and environmental monitoring and/or process deviations (i.e. identifying root cause, recommending corrective/preventative actions, assessing product impact, and summarizing investigations in writing).

The Technical Operations Engineering Specialist may also includes process improvements, batch data analysis, and support for regulatory inspections and specific assignments may be focused in one operational area or span multiple areas.

Key Functions

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

• Conducting investigations for customer complaints and EM or process deviations aimed to prevent recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment | Complete investigational test protocols to determine root cause, product impact, event scope, etc.

• Authoring notifications to applicable Health Authorities, in response to deviations or complaints

• Managing the customer complaint work-in-progress at tier meetings to evaluate complaints, facilitate the discussions to align with technology and quality approvers/representatives

• Evaluate potential deviations, facilitate the discussions to align with technology and quality approvers/representatives on deviation classification and impact assessment

• Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations

• Collaboration across IPT functional areas to drive robust processing and continuous improvement | Continuous improvement may include proactive process improvements, investigation Corrective/Preventative Actions (CAPAs), or value capture projects that seek to improve yield, reduce cost, or lower cycle times

• Supporting team and IPT safety, environmental, and compliance objectives

• Managing investigation timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans

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

• Authoring and updating technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation

Education

• Bachelor or Master of Science degree in Engineering or other equivalent technical field

Required

• Two to three years working in engineering discipline or one year working in GMP manufacturing/technical support of GMP manufacturing operations

• Highly developed communication, leadership and teamwork skills

• Ability to manage projects/work to schedule/deadlines

Preferred

• Customer Complaint investigator

• Deviation Management investigator

• Experience in biologics, vaccine, or bulk sterile manufacturing facilities.

Schedule

• Limited additional shift or weekend coverage may be required based on specific assignments

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.

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.

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.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

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

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:

Click here to request this role’s pay range.

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):

Number of Openings:

Requisition ID:R203132