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Merck Senior Specialist, Process Engineer in Elkhorn, Nebraska

Job Description

The successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation of vaccine product manufacturing facility. You will be working with a team of 7 scientists, select manufacturing managers, highly talented shop floor personnel and on-site engineers (both Mechanical and Industrial) as well as off-site global Engineering.

Primary Responsibilities:

  • Providing technical support for vaccine, biologic, and sterile manufacturing processes in the form of data analysis, troubleshooting, problem-solving, report writing.

  • Ensure seamless and rapid technology transfers from Upstream Process Development through the review of upstream technology transfer protocols and participation on project development teams

  • Supporting change control implementation for manufacturing.

  • Support Lyophilization processes within group as well as Production.

  • Learning new processes and procedures.

  • Recommending, creating, writing process control and automation instructions.

  • Performing off-shift work (only as needed).

  • Conducting technical investigations and analyses. Investigate selected process non-conformances (OOS) and deviations, review and troubleshoot with the help of the team and set CAPA’s.

  • Recommending and implementing corrective and preventative actions and helping lead reduction of atypical events for the area.

  • Provide technical support for site Capital projects.

  • Writing, reviewing, and improving procedures for operation of equipment and processes.

  • Contributing to process and equipment safety reviews.

Education Minimum Requirement:

  • B.S. degree in chemical or biochemical engineering.

Required Experience and Skills:

  • Minimum 5 years post-bachelor’s degree experience in USDA 9CFR or GMP manufacturing and/or technical support of USDA 9CFR or GMP manufacturing operations (or M.S. degree plus 3 years; or PhD degree).

  • Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills.

  • Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, ergonomic risks, ability to automate processes).

  • Understanding of strategic planning and resource management.

Key Competencies include:

  • Demonstrate a working knowledge of biologics production processes and associated equipment.

  • Apply knowledge to streamline production processes and minimize downtime.

  • Understand and incorporate relevant GMPs.

  • Work with site leadership to develop and execute the growth strategy.

Preferred Experience and Skills:

  • Advanced degree (M.S., PhD) in science or engineering (Chemical/Biochemical).

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

  • Six Sigma and/or Lean certification.

  • Regulatory inspection presentation experience with external regulatory authority representatives.

  • Thorough understanding of basic statistical tools for process data analysis.

  • Desire to be part of a team and work together to solve complex issues.

  • Good conceptual, analytical, problem solving, and organizational skills - must be detail-oriented, well organized and able to work independently and in a team environment.

Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society and our planet. We offer one of our industry’s most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species.

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

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, 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.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at [email protected]

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEOC GINA Supplement​ at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocgina_supplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

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:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Thimerosal, Formalin and Antibiotics

Number of Openings:

1

Requisition ID: R62171

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