Merck Sr. Specialist, Engineering in West Point, Pennsylvania
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.
The function of this position is to provide engineering technical support to the manufacture of liquid vaccines. The role encompasses technical services support in the areas of deviation management, equipment and automation systems, validation, and product franchise. Specific assignments may be focused in one area or span across multiple areas of focus.
Serve as Subject Matter Expert (SME) for the Deviation Management team. With in-depth expertise, support and perform 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.
Provide on-the-floor support of operational and technical issues; collaborating with the shop floor to aid in equipment, automation or process troubleshooting or to provide immediate responses to deviations and potential deviations.
Conduct real time investigations with the goal of fully understanding root cause and product impact within three days of event discovery.
Perform customer complaint investigations, 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.
Complete projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times
Manage investigation and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible including change control.
Execute projects and assigned studies in a right-first-time manner.
Prepare source documentation for regulatory filings, supporting and supporting requests for regulatory inspections related to process overviews, investigations, projects and validation.
Author updates to Master Batch Records (production process descriptions) and Standard Operating Procedures.
Support team safety, environmental, and compliance objectives.
Collaborate effectively with the area Managers, Operators/Technicians, support groups (Mechanical Services, Trades, Automation, Technology), Quality, and Planning.
Actively use and champion 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. in Mechanical or Chemical Engineering Degree or other Engineering/Science Degree
Required Experience and Skills:
Engineering or science educational background
Minimum of 4-year post-Bachelor’s degree experience in support of Production, Process Engineering, Validation, Technical Services or related experience
Minimum of 1-year experience in Deviation Management
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:
Hands-on technical services experience in supporting formulation and filling, including manufacturing-scale filling isolators and closed system processing
Experience with troubleshooting biotech equipment and closed system processing.
Experience with MIDAS, SAP, PI, DeltaV, ProCal, TrackWise
Ability to read Piping and Instrumentation Diagrams
Experience with regulatory agency interactions
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 …
We are known as Our Company., Inc., Kenilworth, New Jersey, USA in the United States and Canada and Our Company everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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.
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 email@example.com
For 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.pdf
EEOC GINA Supplement at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocgina_supplement.pdf
OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf
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.
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R93400
- Merck Jobs