Senior Specialist, Operations

Job Description

As part of our companys Vaccine Manufacturing Organization the Durham team is seeking a highly motivated individual to serve as a Senior Operations Specialist within the Operations Manufacturing Support 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 Degree (science/chemical mechanical or electrical engineering preferred)

• Bachelor of Science (B.S.) degree in Engineering (such as Chemical Mechanical Bio-Engineering Bio-Medical Engineering Industrial Engineering etc.) or Science Fields (such as Chemistry Biology Microbiology etc.) strongly preferred

Required Experience and Skills

• Minimum five (5) 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.

Required Skills:

Preferred Skills:

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.

As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.

Learn more about your rights including under California Colorado and other US State Acts

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.