Senior Operations Specialist

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Job Description
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.
In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, this role will be temporarily based in a and exact timing of the departmental move to Rahway, NJ will be communicated at a future date. 
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a Safety First, Quality Always mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
We have an exciting opportunity for a Senior Specialist to join the business support and project management team for a capital project start-up in Durham, North Carolina.  The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.
This position requires the ability to work independently with moderate to minimal supervision, produce/complete various assignments requiring analytical ability, demonstrate independent judgment, creativity and problem-solving skills. This role also requires strong collaboration and communication skills to enable interfacing with both internal contacts (local site level) and external contacts (external customers, above site partners, vendors) to support these initiatives.
The Senior Specialist must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation. To be successful in this role you will need to be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best comprehend and resolve it at the root cause.
Position Description
The duties of the Senior Business Support Specialist include but are not limited to:
Assist with facilitation of Project and site Tier meetings and help manage the site project portfolio.
Lead cross-functional teams to advance project goals.
Manage Project Risk Register.
Assist in developing project controls and metrics to display the overall health of the project.
Partner with Learning & Development to develop learning plans and training system.
Develop and implement plans in partnership with other internal departments and above site and external contacts on different projects and initiatives. 
Effective communication with internal/external customers to manage projects, assignments, and workflow.
Key Competencies 
Critical thinking, problem solving and decision-making skills
Ability to see big picture and identify improvements aligned with business objectives.
Comprehension of program and project management fundamentals including indirect leadership skills.
Prioritization, planning, organizing and delegation skills.
Working with peers, management and both internal and external partners.
Conflict management
Customer focused
Self-directed
Communication with diverse audiences
Strategic end to end thinking
Position Qualifications:
Required Education, Experience and Skills: 
Bachelor's degree in an Engineering or Science or related field with at least five (5) years of in a manufacturing/operations role in a regulated industry OR
Master's degree in an Engineering or Science or related field with at least three (3) years of in a manufacturing/operations role in a regulated industry.
Experience with Project Management and/or indirect leadership
Preferred Experience and Skills:
Experience working in a pharmaceutical, biotech, or vaccines manufacturing environment. 
Lean Six Sigma Green Belt or Black Belt Certification
Experience with aseptic processing operations such as cell culture, filling, and/or lyophilization.
Experience authoring technical documents such as Standard Operating Procedures (SOPs) and change requests within a current Good Manufacturing Practices (cGMP) context
Our Manufacturing & Supply Division is dedicated to be 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. 
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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
Flexible Work Arrangements:
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
Number of Openings:
1
Requisition ID:
R164504
Job Requirements
(see job description above)

Company info

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