Computer System Validation Specialist - Hybrid

Job Description

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.

The Specialist, Digital Foundational Services, IT/OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities. This role reports into the Associate Director of Compliance for above site systems.

Primary Responsibilities:

• Support various site functional and cross functional structures for all computerized system validation
• Support Divisional & Enterprise systems for all computerized system validation and IT/OT compliance issues.
• Responsible for representing compliance activities to internal and external auditors / agencies
• Supports the development of audit responses and engages with local quality organizations on proper strategies when required.
• Responsible for Identifying and engaging in remediation of above site IT/OT compliance risks.
• Execute risk assessments to evaluate the implementation of new technologies or significant changes to existing architectures and technologies.
• Responsible for reporting challenges in execution or adherence to procedural trends due to nonconformance and accountable for the effective and efficient running of all compliance operations in the Automation and IT teams.
• Responsible for reporting status for above site deviations / CAPAs and other quality records that will be used as indicators of control and conformance to policy.
• Responsible for communication and championing changes to the SDLC policies and procedures for Digital Manufacturing Division.
• Responsible to engage as a member of a compliance group that shares knowledge and learnings for better execution and conformance to SOP within Digital Manufacturing Division.
• Liaise with Compliance teams from other sites to ensure consistency and best practices applied.

WHAT YOU MUST HAVE

Qualifications Minimum Requirement:

• High School Diploma required. Bachelor's Degree in Computer Science, Engineering, Regulatory Compliance or a related study preferred.

Required Experience and Skills:

• 2+ years supporting compliance activities.
• Proficient and demonstrated knowledge of regulatory requirements (21CFR part 11, EMEA Annex's 11, etc) that apply to computerized systems validation and compliance for site based as well as divisional and enterprise systems.
• Demonstrated ability to support internal and external auditors / agencies.
• Working knowledge and application of ISA S95 and S88 Standards in GxP environment.
• Good understanding of end-to-end Manufacturing business processes and value streams inclusive of Manufacturing, Quality, and Supply chain.
• Demonstrated ability to partner with stakeholders and navigate across conflicting priorities to balance critical tactical and strategic needs.
• Outstanding written and verbal communication skills - able to effectively communicate complex concepts in simple ways.
• Demonstrated ability to effectively collaborate and communicate with a variety of audiences and stakeholders including executive management, business leaders, IT peers, and colleagues worldwide.
• Strategic thinker, with demonstrated ability to work in a broad and top-down manner with a fair amount of ambiguity.
• Results-orientation with the proven ability and reputation for developing plans and implementing them successfully.
• Self-directed, self-motivated, focused leader who with little direction can fill in the gaps as to what is needed, and drive expected results.
• Technical, operational and business expertise in the following disciplines: Computer Systems Validation, Instrumentation/Automation& Control, Project Management.

NOTICEFORINTERNALAPPLICANTS

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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description

Preferred Experience and Skills:

• Prior experience in the pharmaceutical industry, with specific experience in the Manufacturing, Supply Chain, and Manufacturing Quality areas - ideally involving cross industry collaboration to drive best practices.
• Experience in integrating real time shopfloor and lab systems, at an enterprise level, with appropriate levels of resiliency and performance.
• Experience in manufacturing analytics systems, including supply and demand forecasting, biologics process modelling and advanced image analysis.
• Exposure to multiple, diverse technologies and processing environments.
• Knowledge of business process re-engineering principles and processes.
• Strong understanding of application development methodologies.

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 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected salary range:
$80,320.00 - $126,500.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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

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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
25%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Requisition ID:R249057