Specialist, Engineering

Job Description

If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, 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:

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, manufacturing plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

We are seeking individuals with strong scientific and technical skills to contribute to the design, development and manufacturing of sterile products, making accessible our company's next generation of Vaccines and Biologics. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

We have an exciting opportunity for a Specialist to join the technical operations team supporting a capital project critical to Human Health at our facilities in Durham, North Carolina. This new facility will include end-to-end processing of both drug substance and drug product, including product inspection, and quality control laboratories.

The Specialist, Technical Operations will be responsible for providing technical support as part of one of the drug substance or drug product Technical Operations teams.

Position Responsibilities:

• Reporting to the Technical Operations Associate Director the incumbent will independently manage project assignments and will escalate potential delays and develop remediation plans when possible.

• Design, author and execute protocols in support of the technical transfer using the Technical Operations laboratory facilities and/or full-scale production equipment.

• Assist the capital project through review and approval of facility and equipment commissioning & qualification documents pertaining to utilities, manufacturing equipment and other processes.

• Provides technical support for complex technical problems impacting manufacturing and other investigations including processes and equipment.

• Authors and updates technical and manufacturing documents necessary for change controls, batch records, standard operating procedures, corrective and preventative actions among others.

• Provides on-the-floor support of operational and technical (process/equipment) issues on the shop floor.

• Support quality risk assessments and regulatory inspections.

• Supports team safety, environmental, and compliance objectives.

• Collaborates effectively with the area manufacturing Coaches, Operators and support groups such as Quality and Planning.

Education Minimum Requirement:

• Bachelor's degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline

Required Experience and Skills:

• Minimum of 2 years’ experience in pharmaceutical operations, technical services, and/or quality operations

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

• Flexibility and ability to manage multiple priorities.

• Demonstrates interpersonal, technical aptitude and problem-solving skills

• Communication, leadership and teamwork skills.

Preferred Experience and Skills:

• Sterile cGMP experience in bulk, biologics or pharmaceutical environment.

• Experience using Lean/Six Sigma tools.

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.

Residents of Colorado

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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

EEOC GINA Supplement​

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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.

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:R144048