Job Description
West Point Technical Operations is seeking highly motivated individuals to provide engineering technical support within manufacturing facilities on the West Point site. The focus of the role includes Deviation Management, including Process and Environmental Monitoring Deviation investigations, with the potential for additional areas of responsibility/development depending on the area supported. The deviation management role includes investigation of process deviations (i.e. identifying root cause, recommending corrective/preventative actions, assessing product impact, and summarizing investigations in writing). The other areas of responsibility offer opportunity for further development and rotation to gain experience in different potential functional roles within Technical Operations. Limited additional shift or weekend coverage may be required based on specific assignments.
Individuals selected for this role will spend at initial period of time training and/or gaining deviation management experience within the Deviation Management team prior to movement to an area on the West Point site requiring Deviation Management support.
The individual in this position will be responsible for the following:
Performing deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
As required, manage the IPT deviation management daily huddle to evaluate potential deviations, facilitate the discussions to align with technology and quality approvers / representatives on deviation classification and impact assessment.
Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.
Collaboration across IPT functional areas to drive robust processing and continuous improvement. Continuous improvement may include proactive process improvements, investigation Corrective/Preventative Actions (CAPAs), or value capture projects that seek to improve yield, reduce cost, or lower cycle times.
Supporting team and IPT safety, environmental, and compliance objectives.
Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.
Actively using and championing the use of company Production System (MPS) tools, both in problem solving and day-to-day operational activities.
Authoring and updating technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation
Authoringnotifications to applicable Health Authorities, in response to deviations or complaints, as required.
Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.
Provides technical support to manufacturing for complex problems and issues including process/equipment.
Collaborates effectively with the area Biotechnicians/Operators/Mechanics, support groups, Quality, and Planning.
Required Education / Experience:
Bachelor’s degree in chemical engineering, mechanical engineering, biological sciences, or related discipline.
Minimum 1-year experience in direct experience or support to vaccine/pharmaceutical manufacturing (Technical Operations, Quality, Operations)
Technical writing (e.g. investigations, technical protocols/reports)
Investigative tools (e.g. 5-whys, fishbone).
Strongly Preferred Experience
Two or more years of vaccine/pharmaceutical manufacturing experience (Operations, Technology, or Quality)
Minimum 1-year experience in Deviation management and/or Complaints.
Experience in Trackwise, MEDS, SAP, GLIMS, DeltaV use
Experience in applying company Production System (MPS) tools and mindset, both in problem solving and day-to-day operational activities
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:
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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.
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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:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/26/2024
*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.
