Sr. Specialist, Engineering

Sr. Specialist, Engineering

26 Jun 2024
Pennsylvania, Westpoint 00000 Westpoint USA

Sr. Specialist, Engineering

Vacancy expired!

Job DescriptionOur 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 Senior Specialist, West Point Technical Operations is responsible for providing technical support to one of the vaccine manufacturing areas within Technical Operations. Responsible for implementing continuous improvement projects as well as supporting equipment and investigations as required. Work as an individual contributor, team, or project lead.

Supports executes, and/or leads continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.

Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.

Provides advanced technical support to manufacturing for complex problems and issues including process/equipment.

Designs conduct, and/or reviews and approve experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.

Authors, updates, and/or reviews and approves technical and manufacturing documents necessary for engineering studies, change control.

Supports regulatory inspection activities for the facility

Provides on-the-floor support of complex operational and technical (process/equipment) issues.

Performs and/or reviews and approves 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.

Completes and/or leads 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.

Supports team safety, environmental, and compliance objectives.

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

Collaborates effectively with the area Coaches, Operators/Mechanics, support groups, Quality, Planning, project teams, and external component and equipment vendors.

Education Minimum Requirement:

B.S. Degree in Engineering or other equivalent technical fields

Required Experience and Skills:

Minimum four (4) years’ post-bachelor’s degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance

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:

Change Control author/reviewer

Deviation Management investigator/reviewer

Experience in biologics, vaccine, or bulk sterile manufacturing facilities

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.Who we are …Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.What we look for …In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .INVENT.IMPACT.INSPIRE.NOTICE FOR INTERNAL APPLICANTSIn 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.US and Puerto Rico Residents Only:If you need an accommodation for the application process please email us at staffingaadar@msd.comFor more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdfEEOC GINA Supplement​ at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocginasupplement.pdfOFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdfOFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdfWe are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:DomesticVISA Sponsorship:NoTravel Requirements:No Travel RequiredFlexible Work Arrangements:Not SpecifiedShift:1st - DayValid Driving License:Hazardous Material(s):Number of Openings:8Requisition ID: R59673

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