Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
At our Animal Health campus in Elkhorn, NE, we currently have a Bioprocess Engineer position available within our Biological Technology Solutions (BTS) team (A part of our Global Technical Operations team).
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 6 scientists, select manufacturing managers, highly talented shop floor personnel and on-site engineers (both Mechanical and Industrial) as well as off-site global Engineering.
Responsibilities may include:
- 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.
- 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:
- Master's degree or Bachelor's degree with 2 years of industrial experience in Biopharmaceuticals or equivalent. Ph.D with 0 years industry experience in Biopharmaceuticals or equivalent.
- 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).
- Strong problem-solving skills and a hands-on approach to problem solving, with a bias towards going to see problems for oneself in the facility.
- Desire to be part of a team and work together to solve complex issues.
- Thorough understanding of basic statistical tools for process data analysis.
- Good conceptual, analytical, problem solving, and organizational skills - must be detail-oriented, well organized and able to work independently and in a team environment.
- A "hands-on" energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done. Strong desire to succeed and to help others to do the same.
Preferred Experience and Skills:
- The applicant should have an in-depth knowledge in the principles of process scaling upstream processes from process development to clinical manufacturing, cell culture unit operations, as well as associated single-use technology.
- Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration.
- Experience working in a cGMP environment
- Biologics or vaccine processing
- Sterile processing
- Project management
- Leadership roles
- Participation in regulatory agency inspections
- Familiarity with microbiological, molecular or biochemistry principals
- Strong desire for continuous learning
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
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.
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.
If you need an accommodation for the application process please email us at firstname.lastname@example.org
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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.
Flexible Work Arrangements:
Valid Driving License:
Yes - Thimerosal, Formalin and BEI (Binary ethylenimine)
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