Specialist, Engineering - Deviation Management - Military Veterans

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

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. 

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.  To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. 

The Specialist, Technical Operations Engineer in this position within the Incoming Materials IPT within the Shared Services E2E will be responsible for providing technical support and execution of investigative quality notifications (iQNs). They will be responsible for providing and occasionally leading technical support to the manufacturing areas. The individual will work as an individual contributor, adding to the performance and results of the department. Provides technical guidance. Anticipates and interprets client and/or customer needs to identify and implement solutions. Minimal supervision, guidance, and direction is employed by the supervisor, however, periodic checks and reports are required to review soundness of technical judgment and the status/schedule of the effort. Individual will also be responsible for:

• Manage investigative events from notification through closure.

• Support and/or execution of continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.

• Examination of an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.

• Design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.

• Authoring and updating technical and manufacturing documents necessary for engineering studies or process demonstrations.

• Support of regulatory inspection activities for the facility

• Providing on-the-floor support of operational and technical (process/equipment) issues on the shop floor.

• Completing 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.

• Supporting team safety, environmental, and compliance objectives.

• Managing project and investigation timelines to ensure key compliance and customer due dates are met; escalating any potential delays and develop remediation plans when possible.

• Collaborating effectively with various operational areas, support groups, Quality, and Planning

Education Minimum Requirement:

• Bachelor’s Degree or higher (Engineering or Sciences, preferred)

Required Experience and Skills:

• Two (2) years post-bachelor’s degree experience in GMP manufacturing/laboratories and/or technical support of GMP manufacturing operations/laboratories.

• Experience in deviation management and/or change control and/or equipment support and/or project support role.

• Highly developed communication, leadership and teamwork skills.

• Ability to manage projects/work to schedule/deadlines.

Preferred Experience and Skills:

• Experience in biologics, vaccine, or bulk sterile manufacturing facilities.

• Change Control author

• Deviation Management Investigator

If you need an accommodation for the application process please email us at staffingaadar@merck.com For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster EEOC GINA Supplement​ OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R37984