Job Description
Position Description
The function of this position is to provide engineering technical support to the manufacture of liquid vaccines. The role encompasses technical services support with primary focus in the area of deviation management along with other areas such as validation and product franchise support. Specific assignments maybe focused in one area or span across multiple areas of focus.
The field engineer will be responsible for:
Providing on-the-floor support of operational and technical issues; collaborating with the shop floor to provide immediate responses to deviations and potential deviations.
Conducting real time investigations with the goal of fully understanding root cause and product impact within five days of event discovery.
Performing deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc
Completing projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and continuous improvement projects that seek to improve yield, reduce cost, or lower our processing cycle times.
Preparing source documentation for regulatory filings, supporting requests for regulatory inspections related to process overviews, investigations, projects and validation.
Authoring updates to Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures).
Supporting team safety, environmental and compliance objectives.
Managing investigation, project and validation study timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.
Collaborating effectively with the area Coaches, Operators/Mechanics, support groups (Maintenance, Automation, Technology, Quality, and Planning).
Executing projects and assigned studies in a right-first-time manner.
Actively using and championing the use of Lean Six Sigma (LSS) and our Production System (MPS) tools, both in problem solving and day-to-day operational activities
Position Qualifications:
Education Minimum Requirement:
B.S. or B.A. in Mechanical or Chemical Engineering degree or other science degree
Required Experience and Skills**:
Engineering or science educational background
2 years of relevant work experience
Demonstrated ability to work both independently and as a part of a team.
Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills
Preferred Experience and Skills:
Support of vaccine operations or technical services support.
Experience with troubleshooting biotech equipment and closed system processing.
Experience with MEDS, SAP
Ability to read Piping and Instrumentation Diagrams
Support of deviation investigations and/or project work
LSS/MPS certification / experience
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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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:
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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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
01/7/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R327641