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.
Supporting the regional sites in Ames, IA; Worthington, MN and DeSoto, KS, the Engineering Technical Management Specialist witll:
- Provide tactical and strategic leadership in the execution of product transfers for existing products between manufacturing sites as well as from R&D and BTS into manufacturing facilities.
- Ensure relevant technical information including development reports, Includes the development of process and equipment validation strategies. Provides support from pre-license through commercial production.
- Manage and lead product transfers for site to site and from R&D. Includes supporting the
- Verify process transfer documentations are completed in a timely fashion including but not limited to change controls, protocols, reports, manufacturing records, and standard operating procedures.
- Ensure compliance to internal standards and regulatory guidelines
- Effectively conduct root cause investigations and implement corrective actions
- Understand facility throughput and bottlenecks, supports programs to drive continuous improvement and productivity
- Lead implementation of new technology and new applications of existing technology.
- Provide input during Basis of Design (BOD) and Detailed Design during capital projects, applying good maintenance and reliability engineering principles.
- Establish relationships with key stake holders and serves as resource for technical issues in product development and manufacturing.
- Identify technical training gaps and provide input into the resolution of these gaps.
Education Minimum Requirement:
- A minimum of a Bachelor’s Degree is required.
- A degree in Engineering or Science is preferred.
- Advanced degree is also preferred.
Required Experience and Skills:
- At least ten (10) years of experience in a pharmaceutical/biological field in Operations, Quality, Technical or R&D.
- Demonstrated project management skills
- Analytical and problems solving skills
- Experience in product development and manufacturing of pharmaceuticals/biologics
Preferred Experience and Skills:
- Experience in the development and manufacturing of veterinary vaccines
- Experience in aseptic processing
- Experience in product transfer, Pre-Licensing Serial production and process validation
- Demonstrated use of project management tools to support transfers (i.e. Microsoft Project)
- Use of Lean Six Sigma tools and a certification as Green or Black Belt
- Understanding of manufacturing tools like SAP, Reliance, etc.
- Knowledge of Validation standards and practices
- USDA/VMD Regulatory requirements for veterinary vaccine registration and manufacturing
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 email@example.com
For more information about personal rights under Equal Employment Opportunity, visit:
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
VISA Sponsorship: No
Travel Requirements: 25%
Flexible Work Arrangements:
Valid Driving License:
Number of Openings: 1
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