Associate Specialist, Engineering at Merck & Co, Inc in West Point, PA
Job Description New Hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for Covid-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law. 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 Technical Operations team is seeking a highly motivated individual to fill an open position to support the start-up of a new bulk vaccine manufacturing facility at the West Point, Pennsylvania site.Facility start-up will include commissioning, qualification and process equipment, automation testing and qualification, and technology transfer of vaccine intermediate manufacturing process to support successful licensure of new facility. The Associate Specialist, Technical Operations is responsible for technical support for bulk vaccine manufacturing unit operations while actively supporting, participating in, and embracing an empowered team culture.In this role, the Associate Specialist will work as an individual contributor as well as a team member within a cross-functional group that includes Global Engineering Services, Global Technical Operations, West Point Operations, Quality, Automation, our Research & Development Division, and others.Additional responsibilities include:
Support successful demonstration of unit operations within the polysaccharide vaccines manufacturing process for the technology transfer of bulk vaccine manufacturing support process within new manufacturing facility Support successful technology transfer of bulk drug product manufacturing process within new manufacturing facility Partner with cross functional team to develop process/ procedures and complete successful qualification of equipment/process for unit operation 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 Provide technical expertise for unit operation for quality risk assessments and qualification testing Author and update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation Author, implement, and provide technical support for electronic batch record for unit operation Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings Design and conduct experimental protocols as needed using lab facilities and/or production equipment at full scale Support process and continuous improvement projects and complex manufacturing investigations Support digital and data integrity initiatives for the project Provide technical support to manufacturing for complex problems and issues Develop and assure consistent application of standardized work, engineering, and process tools Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause Support regulatory submission preparation and inspections for the facility Support team safety, environmental, and compliance objectives Education Minimum Requirements:
Bachelor's Degree in Engineering or Science at time of Start Required Experience and Skills:
1 year of relevant technical experience Demonstrated effective written and verbal communication skills Demonstrated ability to work both independently and as a part of a team Preferred Experience and Skills:
Strong technical problem-solving abilities Strong collaboration and leadership skills Experience with Vaccine Manufacturing Operations and/or GMP manufacturing Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time. #Classof22 Who we are We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD 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 Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today. 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. 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. For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement Pay Transparency Nondiscrimination 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. 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:
Regular Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
No Travel Required Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
2
Salary Range:
$80K -- $100K
Minimum Qualification
Technical SupportEstimated Salary: $20 to $28 per hour based on qualifications.
Support successful demonstration of unit operations within the polysaccharide vaccines manufacturing process for the technology transfer of bulk vaccine manufacturing support process within new manufacturing facility Support successful technology transfer of bulk drug product manufacturing process within new manufacturing facility Partner with cross functional team to develop process/ procedures and complete successful qualification of equipment/process for unit operation 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 Provide technical expertise for unit operation for quality risk assessments and qualification testing Author and update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation Author, implement, and provide technical support for electronic batch record for unit operation Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings Design and conduct experimental protocols as needed using lab facilities and/or production equipment at full scale Support process and continuous improvement projects and complex manufacturing investigations Support digital and data integrity initiatives for the project Provide technical support to manufacturing for complex problems and issues Develop and assure consistent application of standardized work, engineering, and process tools Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause Support regulatory submission preparation and inspections for the facility Support team safety, environmental, and compliance objectives Education Minimum Requirements:
Bachelor's Degree in Engineering or Science at time of Start Required Experience and Skills:
1 year of relevant technical experience Demonstrated effective written and verbal communication skills Demonstrated ability to work both independently and as a part of a team Preferred Experience and Skills:
Strong technical problem-solving abilities Strong collaboration and leadership skills Experience with Vaccine Manufacturing Operations and/or GMP manufacturing Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time. #Classof22 Who we are We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD 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 Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today. 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. 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. For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement Pay Transparency Nondiscrimination 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. 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:
Regular Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
No Travel Required Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
2
Salary Range:
$80K -- $100K
Minimum Qualification
Technical SupportEstimated Salary: $20 to $28 per hour based on qualifications.
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