Job Description
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.
The West Point Technical Operations 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.
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Job function:
- Provide technical support for live virus drug substance manufacturing, applying technical skills to align activities with department, site, and franchise objectives.
- Serve as the technical lead for stock seed manufacturing and inventory management which includes cross-functional collaboration with groups such as Operations, Quality, CMC, and Supply Chain.
- Monitor the health of the process through continuous monitoring and/or continuing process verification activities.
- 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 collaborate with cross-functional peers at site and above-site as required.
- Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve manufacturing challenges.
- Provides on-the-floor support of complex operational and technical (process/equipment) issues.
- Author and update technical and manufacturing documents necessary for change control, investigations, process design/definition, engineering studies, and process demonstrations.
- Prepare documentation to support regulatory submission and participate in regulatory inspection activities for the facility.
- Support team safety, environmental, and compliance initiatives.
Education Minimum Requirement and Experience:
- Bachelor of Science (BS) degree in Engineering or Sciences with five (5) years' experience in GMP manufacturing and/or technical support of GMP manufacturing operations OR
- Master of Science (MS) degree in Engineering or Sciences with three (3) years' experience in GMP manufacturing and/or technical support of GMP manufacturing operations
Required Experience and Skills:
- Experience in project support and/or change control and/or deviation management and/or manufacturing support role.
- Highly developed communication, leadership, and teamwork skills.
- Ability to manage projects to ensure timely completion of project milestones.
- Demonstrated strategic ability to develop innovative solutions for undefined problems and business processes to meet the needs of key stakeholders and project sponsors.
Preferred Experience and Skills:
- Experience in biologics, vaccine, or bulk sterile manufacturing facilities
- Understanding of sterile and aseptic processing
- Proficiency in the following competencies: flexibility, motivation, teamwork/collaboration, problem-solving, and project management
- Demonstrated competency in change control procedures
- Proficient with data analytics and/or presentation (ex. JMP, Spotfire, PowerBI)
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.
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:
No relocation
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:
10/18/2024
*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.
Requisition ID:R317019