Assoc. Scientist, Engineering - Military Veterans

Job Description

Job Description:

Our Engineers support internal and external manufacturing operations to 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.

The West Point Lyophilization Technical Operations organization is seeking a highly motivated individual for a 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.

Position Description:

The Specialist, West Point Technical Operations is responsible for providing technical support to the lyophilized vaccine manufacturing areas within Technical Operations. Responsible for implementing continuous improvement projects as well as supporting equipment and investigations, as required.

• Provide technical support for Live Virus Vaccines (LVV) drug product manufacturing at our company's West Point Processing Facility.
• Supports team safety, environmental, and compliance initiatives.
• Apply technical skills to align activities with department, site and franchise objectives.
• 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.
• Update Electronic Batch Records as needed.
• 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 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. This includes Continued Process Monitoring (CPV).
• 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.
• Troubleshoots process and equipment related issues.

Education Minimum:

• B.S. degree in Engineering or Sciences

Required Experience and Skills:

• Minimum 2 years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations
• Experience in change control and/or deviation management and/or equipment support and/or project support role.
• Strong problem-solving skills.
• Highly developed communication, leadership and teamwork skills
• Ability to manage projects/work to ensure timely completion.

Preferred Experience and Skills:

• Experience in biologics, vaccine or bulk sterile manufacturing facilities.
• Understanding of sterile and aseptic processing
• Experience with Data Analytic Tools (Spotfire, Pipeline Pilot, MANTIS, Power BI, JMP etc.)
• Experience with Quality Risk Assessment (QRA)
• Experience with Electronic Batch Records.
• Proficient in the following competencies: flexibility, motivation, teamwork/collaboration, problem-solving, and project management.
• Chemical Engineering, Mechanical Engineering, Biomedical Engineering or Biological Sciences degree.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
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.

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
02/3/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.