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Senior Specialist, Operations
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Job Description
Position Description
As part of our company's Vaccine Manufacturing Organization, the Durham team is seeking a highly motivated individual to serve as a Senior Operations Specialist within the Operations Manufacturing Support team. In this role, you must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation. This role requires the ability to distill large quantities of complex data into simplified reporting and actionable measures, strong problem-solving skills, rapid disciplined decisions and prioritization of work. The position must also demonstrate strong collaboration and communication skills to enable interfacing with both internal contacts (site level) and external contacts (external customers, sister sites, vendors) to support these initiatives.
The position requires strong leadership, technical writing, and problem-solving skills. You will lead and/or support critical project initiatives at the site, support the ongoing sterility assurance program, and be involved in developing and implementing corrective actions. Enthusiasm for continuously learning is a requirement.
Responsibilities include, but are not limited to:
Education Minimum Requirement
Required Experience and Skills
Preferred Experience and Skills
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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA 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.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/17/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R316792
Position Description
As part of our company's Vaccine Manufacturing Organization, the Durham team is seeking a highly motivated individual to serve as a Senior Operations Specialist within the Operations Manufacturing Support team. In this role, you must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation. This role requires the ability to distill large quantities of complex data into simplified reporting and actionable measures, strong problem-solving skills, rapid disciplined decisions and prioritization of work. The position must also demonstrate strong collaboration and communication skills to enable interfacing with both internal contacts (site level) and external contacts (external customers, sister sites, vendors) to support these initiatives.
The position requires strong leadership, technical writing, and problem-solving skills. You will lead and/or support critical project initiatives at the site, support the ongoing sterility assurance program, and be involved in developing and implementing corrective actions. Enthusiasm for continuously learning is a requirement.
Responsibilities include, but are not limited to:
- Supports the end-to-end product Value Stream Map driving production improvements, inventory management, cost reductions, and standard work at the shop floor level.
- Collaborates with Operations, Technology and Quality to author regulatory inspection observation responses and completes remediation projects, as required.
- Assists shift managers in providing leadership to the production floor. Capable of providing primary leadership to team during extended periods of manager absence such as vacations
- Serves as liaison between the team and support groups in resolving day to day issues and in support of various projects and initiatives including the tech transfer of new products.
- Author and own execution of Operations protocols
- Develop and own Operations corrective actions.
- Author and revise Standard Operating Procedures
- Support of internal and external regulatory inspections, presenting on topics as needed.
- Executes and manages Operations batch record review within established timelines for release and effectively liaisons with Quality to resolve comments in a timely manner.
- Day shift Operations representative for various site needs (Quality Assessments, Process Simulation support, etc.)
- Leads/Supports production and quality projects and process system improvements.
- Lead problem-solving of real-time shop floor issues.
- Support investigations of process deviation events
- Provide expertise to the production floor, understanding the full process requirements (safety, compliance, equipment, regulatory) in order to best understand and resolve production issues.
- Works independently and is capable of balancing shifting priorities without introducing disruption to the organization. Capable of working through uncertainty with minimal levels of manager direction.
- Potential to work on shift directly with an Operations team as needed for shop floor support.
Education Minimum Requirement
- Bachelor's degree (science/chemical, mechanical, or electrical engineering preferred)
Required Experience and Skills
- Minimum four (4) years of relevant experience in a manufacturing, technical, or mechanical support role in a high-volume lean operation
- Technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols.
- Must be able to work both independently and within multi-functional teams in a fast-paced environment.
Preferred Experience and Skills
- Sterile manufacturing shop floor experience highly preferred.
- Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.
- Experience with formal problem-solving techniques and a hands-on approach to problem-solving, such as root cause analysis and/or Lean Six Sigma tools.
- Experience using inventory management and maintenance planning software (MRP/ERP) such as SAP, automated control systems and electronic batch record systems.
- Experience managing against metrics and scorecards in a business environment.
- Experience with presenting to an internal / regulatory auditor.
- Advanced knowledge of Excel, Minitab, JMP, and/or Statistical analysis.
- Six Sigma certification.
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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA 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.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/17/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R316792
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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