at Merck in Dover, Delaware, United States
Job Description
Job Description
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.
Responsibilities include:
+ Maintenance of existing raw material and single use component supply chain data.
+ Supplier change management including evaluation of changes for downstream pharmaceutical product regulatory impact.
+ Planning, execution and closeout (end to end) of product change control documentation associated with supplier changes.
+ Change control management supporting existing raw material and single use component supply chains.
+ Change control planning and execution supporting franchise / globally implemented process changes.
+ Close interaction and coordination with local and extended network (US, EU) manufacturing facilities and global franchise management in support of global changes.
+ Tracking and communication of metrics associated with change control and supply management.
+ Management of supplier complaints (from submission to closeout), including close association with global level supplier complaint communities of practice.
+ Design and execution of continuous improvement projects in support of these responsibilities, including procedure and form management.
The successful candidate must have:
+ Hands on experience with Change Management.
+ Strong verbal and written communication skills, team skills, personal character, and ethics.
+ Strong problem-solving skills and a hands-on approach to problem solving.
+ Supplier relationship experience is preferred but not required.
+ Enthusiasm, confidence, and initiative-taking ability needed for continuous learning.
+ Strong desire to succeed and to help others do the same.
Qualifications
Education Minimum Requirement:
+ A bachelor’s degree in science, engineering or equivalent discipline with 1or 2+ of years’ experience in a cGMP environment (technical, and/or quality).
Required Experience and Skills:
+ Technical knowledge to differentiate between chemical substance properties, storage conditions and differences in quality grades.
+ Technical knowledge to differentiate processing equipment (can differentiate between equipment types, example: a butterfly from a rotary from a diaphragm valve).
+ Ability to clearly communicate requirements and expectations with stakeholders with varied technical and non-technical backgrounds (business, quality, engineering, manufacturing, supply chain, production systems and compliance frameworks).
+ Change control experience.
+ Knowledge of compendial differences and requirements for raw materials, single use components and other GMP supply items.
+ GMP compliant documentation practices and data integrity.
Preferred Experience and Skills:
+ Understanding of supply chain assessments and evaluation processes.
+ SAP® software knowledge for identification and tracking of affected products, and supply chain relationships preferred.
+ Supplier relationship / point of contact experience.
+ Tracelink® software experience.
+ Supplier transparency principles.
+ Regulatory audit participation.
+ Understanding of regulatory provisions associated with change control (FDA, MHRA, USP, EUDRALEX, CHP, JP and others) preferred.
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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., Rahway, 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.
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 health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
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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.
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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 C
