Merck Associate Specialist, Engineering - Technical Operations in West Point, Pennsylvania
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 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.
Key vaccine product franchises are experiencing significant growth requiring staffing. This is a rotational assignment as the candidate will initially be assigned to technical operations at the West Point site within vaccine bulk processing (9 months to 1 year) and will then transition to a full-time assignment to support active capital projects in Durham, NC, to increase vaccine bulk manufacturing capabilities.
The Associate Specialist, Engineering - Technical Operations in the BioBacterial Manufacturing End-to-End provides engineering technical support to the manufacture of microbial vaccines while actively supporting, participating in, and embracing an empowered team culture. In this role, the Associate Specialist will work as an individual contributor. Additionally, this role will contribute to the performance and results of a department, and work with other tech services team members to interpret client and/or customer needs to identify and implement solutions. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments.
The role encompasses technical operations support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be focused in one area or span across multiple areas of focus.
The selected candidate will be responsible for:
Provide 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
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 Company Production System (MPS) tools, both in problem solving and day-to-day operational activities
Education Minimum Requirement:
- B.S. or B.A. in Engineering, Sciences, or related discipline
Required Experience and Skills:
Engineering or science educational background
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:
Minimum 6 months of relevant work experience
Support of vaccine operations or technical services support.
Experience with troubleshooting biotech equipment and closed system processing.
Experience with Trackwise, MIDAS, SAP
Ability to read Piping and Instrumentation Diagrams
Support of deviation investigations and/or project work
LSS/MPS certification / experience
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 .
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.
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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.
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R14914
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