Sr Specialist and Validation/Engineering Job in America 2020
Job Description for Sr Specialist and Validation/Engineering Job in America 2020
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.
Responsibilities for Sr Specialist and Validation/Engineering Job in America 2020:
- Provide Validation support for bulk vaccine manufacturing at our Company’s Millsboro Facility.
- Supports team safety, environmental, and compliance initiatives.
- Apply technical skills to align activities with department and Site.
- Work as a team member on continuous improvement projects, complex manufacturing investigations, process improvement, and/or validation projects.
- Completes projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times.
- Manage project work to ensure due dates are met; escalating when necessary and developing remediation plans when possible.
- Effectively collaborates with cross-functional peers.
- Has the ability to examine an issue from diverse compliance perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve manufacturing challenges.
- Author and review validation protocols, change controls, CAPA’s, deviations, SOP’s, and technical reports.
- Monitor the health of the process through continuous monitoring and the annual process review or continuing validation activities.
- Investigate and resolve validation test failures and/or atypical events which require an application of a variety of investigational techniques and analysis, and cross-functional partnering to draw sound scientific conclusions with respect to validation compliance and/or product quality impact.
- Assure consistent application of standardized work, engineering, and process tools.
- Provides on-the-floor support of complex operational and technical (process/equipment) issues.
- Author and update technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control, and validation.
Education Minimum Requirement for Sr Specialist and Validation/Engineering Job in America 2020:
- B.S. degree in Engineering or Sciences.
- Minimum 2 years post-bachelors degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations
Required Experience and Skills for Sr Specialist and Validation/Engineering Job in America 2020:
- Experience in change control and/or deviation management and/or equipment support and/or project support role.
- Strong problem-solving skills.
- Developed communication, leadership, and teamwork skills.
- Ability to manage projects/work to ensure timely completion.
Preferred Experience and Skills for Sr Specialist and Validation/Engineering Job in America 2020:
- Experience in biologics, vaccines, or bulk sterile manufacturing facilities.
- Understanding of sterile and aseptic processing
- Validation experience (process, cleaning, sterilization)
- Proficient in the following competencies: flexibility, motivation, teamwork/collaboration, problem-solving, and project management.
- Change Control author or experience with change control procedures.
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 …
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 fro Sr Specialist and Validation/Engineering Job in America 2020
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 accommodation for the application process please email us at [email protected]
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
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.