Senior Manufacturing Engineering Specialist
West Point, PA
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.
We are seeking a Growth and Improvement minded Senior Manufacturing Engineering Specialist that can help drive our Strategic Operating Priorities.
Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us
Summary, Focus and Purpose
The West Point Technical Services organization is seeking a highly motivated individual for a Senior Specialist – Engineering position. The successful candidate will have the opportunity to contribute to the performance and results of the manufacturing area by providing technical guidance and anticipating and interpreting customer needs to identify and implement solutions.
Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
Provide technical support for the vaccine bulk manufacturing area
Supports team safety, environmental, and compliance initiatives
Apply technical skills to align activities with department, site and franchise objectives
Lead and/or works 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 timelines to ensure key compliance and customer due dates are met; escalating when necessary and developing remediation plans when possible
Effectively collaborates with cross functional peers on site and above site
Ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve manufacturing challenges
Monitor the health of the process through continuous monitoring and the annual process review or continuing validation activities
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
Prepare documentation to support regulatory submission and participates in regulatory inspection activities for the facility
Required | B.S. degree in Engineering or Sciences
Preferred | M.S. or PhD in Science or Engineering
Experience | Skills | Knowledge
Five years post-Bachelor degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations | Master degree with three years experience in GMP manufacturing and/or technical support of GMP manufacturing operations | Ph.D degree with one years experience in GMP manufacturing and/or technical support of GMP manufacturing operations
Demonstrated strategic ability to develop innovative solutions for undefined problems and business processes to meet the needs of key stakeholders and project sponsors.
Highly developed and principled communication, leadership and teamwork skills
Ability to manage projects to ensure timely completion of project milestones
Experience in Cell Culture, Virology, or Industrial Microbiology
Expertise in Cell Culture, Virology, or Industrial Microbiology
Experience in biologics, vaccine or bulk sterile manufacturing facilities
Good understanding of sterile and aseptic processing
Regulatory inspection presentation experience with external regulatory authority representatives
Proficient in the following competencies: flexibility, motivation, teamwork/collaboration, problem-solving, and project management
Demonstrated competency in Change Control procedures
Proficient with data analysis (JMP, Spotfire, DataI KU)
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 …
We are known as Merck & Co., Inc., Rahway, 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.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.
Travel Requirements:No Travel Required
Flexible Work Arrangements:On-Site
Shift:1st - Day
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