Senior Specialist, Computer System Validation

at Merck in Dover, Delaware, United States

Job Description

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

The mission of Quality Assurance is to: safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies.

Primary Responsibilities:

+ As a member of our company’s Research Laboratories Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality organization and for the R&D division.

+ For our Clinical Supply, act as the Quality Unit representative for information technology products such as infrastructure, business applications, standalone, laboratory instrument systems and manufacturing automation systems.

+ Endorse and build Quality Management System elements into the end-to-end computer system validation process, thereby promoting permanent inspection readiness.

+ Develop and maintain a subject matter expert level of comprehension for the company’s Policies, Procedures and Quality Manuals governing computer system validation activities.

+ Consult, assess and assist with risk-based, tailored approaches for computer system validation activities and testing.

+ Provide independent Quality Assurance oversight for the implementation of new computerized systems, change control involved with existing computerized systems as well as the retirement of computerized systems in the Clinical Supply domain.

+ Develop and maintain an overall computer system validation posture and program for a defined functional area(s) (single point of contact) within Clinical Supply, including support for System Development Life Cycle deliverables and testing.

+ Act as a liaison with respect to the Quality Management System and Compliance pillars of Global Development Quality for the purposes of investigations, corrective action/preventive action, procedural controls, auditing and Quality Risk Management.

+ As required, participate in Regulatory Agency inspection activities.

+ Deliver stewardship for our company’s corporate initiatives from a Quality Assurance perspective, such as the Data Governance and Corporate Resiliency programs.

+ Identify and incorporate continuous improvements into computer system validation activities and standards. Leverage external affiliations in order to evaluate current trends.

+ Collaborate and establish relationships with key stakeholders in the Business and Technical Units, including external suppliers.

Education Minimum Requirement :

+ B.S. and/or M.S. degree in an appropriate Life Science, Computer Science, Information Technology or Engineering discipline.

Required Experience and Skills:

+ Experience working in a Pharmaceutical/Biotechnology industry; experience working in a health authority regulated (e.g. GMP) environment.

+ Minimum of 5 years of industry experience including computer system validation, System Life Cycle (SLC), software validation, and/or Quality Assurance functions.

+ High level of expertise and exposure with agency regulations, such as 21 CFR Part 11, Part 58, Part 210, Part 211 from the US Food and Drug Administration.

+ High level of expertise in SLC methodology (e.g., V-model, waterfall, agile, spiral) including change management.

+ Extensive experience providing oversight for adherence to enterprise SLC and procedures.

+ Proficient skills dealing with and comprehension typical laboratory facilities and equipment.

+ Proficient skills dealing with and comprehension automation systems found on the operations shop floor.

+ Ability to prioritize and manage multiple initiatives projects concurrently.

+ Excellent social skills including the ability to work as a team member in a collaborative environment.

+ Excellent written and communication skills including thorough knowledge of Good Documentation Practices.

+ Possess excellent time management skills.

+ High attention to detail.

Preferred Experience and Skills:

+ Experience with calibration and qualification.

+ Expertise with configuration management.

+ Knowledge of published regulatory agency data integrity guidance.

+ Moderate level of experience with electronic tools such as software providing document management and testing capabilities.

+ Some level of experience with IT Infrastructure Language and service management.

+ Comprehension of Pharma 4.0 and next-generation information technology platforms.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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 …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.


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.

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Job Posting: JC195049654

Posted On: Oct 16, 2021

Updated On: Oct 24, 2021