Technical Business Analyst
Job Description New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law,to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in customer facing commercial or research based roles, will be required to be fully vaccinated as a condition of employment. Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The Senior Specialist supports Vaccines and Biologics Manufacturing in West Point. The candidate is responsible for providing site based Project Management, Project Execution, Business Analysis and Technical Support for IT Systems in use in manufacturing of vaccine product at the West Point site. In particular, this position has a heavy component of all local based support of 4 Production instances of MES and it's associated shopfloor hardware. All work will be in compliance with SDLC, GMP, safety, and environmental regulations. The candidate works with manufacturing personnel on developing and executing both business and IT led projects that drive positive business outcomes while ensuring enhanced IT security and resiliency. Knowledge of shop floor networking at our Company and its interaction with the systems in the area will be needed in the role. Primary
Responsibilities:
Understands and supports all GMPs, safety, and environmental regulations. Periodically reviews technical documents and GDLs/SOPs to ensure compliance with GMP and safety. Coordinate with all impacted manufacturing areas for all scheduled MES application downtime (monthly reboot, downtime for DB patch, security patches and others) Generate local change control document for master data change and equipment change with review, follow up, execution of the changes, verify changes and complete change control, update SCS and get them to approval Generate SDLC documentation URS, SCS, QAP, RTM , IOQ and others for new system and upgrade Troubleshoot system problems and work with AMS and above site Process user access forms and grant user access Update MES and eShopFloor SOPs, RS and Test Scripts for each application release Uses technical knowledge to assure the efficient operation of variety of IT systems. Oversees investigations of IT anomalies to prevent recurrence. Participates in audits and training programs in the area of responsibility. Develops and maintains technical documentation. Provides client services support for business area IT applications. The candidate will need to be knowledgeable of the IT systems and standards at our Company to help the client area drive the most benefit from IT. Supports IT Portfolio Process by facilitating creation of Business Cases for new demand Works with IT support organizations (GTO, AMS, ITRMS, etc.) to communicate and minimize the impact of IT changes on manufacturing activities. Manages the relationship between support organizations and the business to ensure a positive, productive experience. Engages with IT support organizations to drive quick resolution to IT incidents, investigate root cause and prevent recurrence Collaborates with IT Risk Management group to understand cyber security threats and to ensure that site computing is current on anti-virus patching and safe computing practices. Works with ITRMS to ensure that SFN firewall rules provide appropriate protection from external threats and allow legitimate business traffic to flow Education Minimum Requirement:
B.S. or B.A.
Qualifications:
Minimum five years of MES support experience Minimum five years SDLC and IT Support experience Relevant work experience encompassing a working knowledge of FDA regulatory requirements Strong leadership, communication (written and oral) and interpersonal skills. Preferred Skills:
Understands and has relationships with the various company IT support organizations and manufacturing areas Our Support Functions deliver services and makes recommendations about ways to enhance our workplace and the experience of working at our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security. 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. Residents of Colorado Click here to request this role's pay range. 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:
10% Flexible Work Arrangements:
Telecommuting Shift:
1st - Day Valid Driving License:
Yes Hazardous Material(s):
Number of Openings:
1
Salary Range:
$80K -- $100K
Minimum Qualification
Technical Product Management, Business Intelligence & AnalyticsEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Understands and supports all GMPs, safety, and environmental regulations. Periodically reviews technical documents and GDLs/SOPs to ensure compliance with GMP and safety. Coordinate with all impacted manufacturing areas for all scheduled MES application downtime (monthly reboot, downtime for DB patch, security patches and others) Generate local change control document for master data change and equipment change with review, follow up, execution of the changes, verify changes and complete change control, update SCS and get them to approval Generate SDLC documentation URS, SCS, QAP, RTM , IOQ and others for new system and upgrade Troubleshoot system problems and work with AMS and above site Process user access forms and grant user access Update MES and eShopFloor SOPs, RS and Test Scripts for each application release Uses technical knowledge to assure the efficient operation of variety of IT systems. Oversees investigations of IT anomalies to prevent recurrence. Participates in audits and training programs in the area of responsibility. Develops and maintains technical documentation. Provides client services support for business area IT applications. The candidate will need to be knowledgeable of the IT systems and standards at our Company to help the client area drive the most benefit from IT. Supports IT Portfolio Process by facilitating creation of Business Cases for new demand Works with IT support organizations (GTO, AMS, ITRMS, etc.) to communicate and minimize the impact of IT changes on manufacturing activities. Manages the relationship between support organizations and the business to ensure a positive, productive experience. Engages with IT support organizations to drive quick resolution to IT incidents, investigate root cause and prevent recurrence Collaborates with IT Risk Management group to understand cyber security threats and to ensure that site computing is current on anti-virus patching and safe computing practices. Works with ITRMS to ensure that SFN firewall rules provide appropriate protection from external threats and allow legitimate business traffic to flow Education Minimum Requirement:
B.S. or B.A.
Qualifications:
Minimum five years of MES support experience Minimum five years SDLC and IT Support experience Relevant work experience encompassing a working knowledge of FDA regulatory requirements Strong leadership, communication (written and oral) and interpersonal skills. Preferred Skills:
Understands and has relationships with the various company IT support organizations and manufacturing areas Our Support Functions deliver services and makes recommendations about ways to enhance our workplace and the experience of working at our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security. 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. Residents of Colorado Click here to request this role's pay range. 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:
10% Flexible Work Arrangements:
Telecommuting Shift:
1st - Day Valid Driving License:
Yes Hazardous Material(s):
Number of Openings:
1
Salary Range:
$80K -- $100K
Minimum Qualification
Technical Product Management, Business Intelligence & AnalyticsEstimated Salary: $20 to $28 per hour based on qualifications.
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