U.S. Capital Project Computer Systems Validation, Specialist (Hybrid)

Job Description

The Digital Foundational Services, U.S. Capital Project CSV, Specialist 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 to the Assoc. Director of Compliance and will report to a cluster lead for the EMEA / AP or US region.

Primary Responsibilities:

• Delivery of best-in-class computer systems validation to capital projects.
  
• Drive the adoption of automation validation standards to capital projects.
  
• Liaise with site Compliance/Validation colleagues and coordinate activities across sites.
  
• Ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC), Cyber Security and Data Integrity to ensure manufacture and supply of quality pharmaceuticals.
  
• Liaise with product teams/technology functions and act as an SME on computer validation for capital projects in the region.
  
• Provision of ongoing validation, training and compliance coaching and support.
  
• 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 IT/OT compliance risks.
  
• Execute risk assessments to evaluate the implementation of new technologies or significant changes to existing architectures and technologies
  
• Support local teams with quality and compliance challenges and executions on how to comply with SOPs and or policies
  
• Responsible for reporting challenges in execution or adherence to procedural trends due to nonconformance.
  
• Responsible for communication and championing changes to the SDLC policies and procedures adopted by the capital project
  
• Responsible to engage as a member of a compliance group that shares knowledge and learnings for better execution and conformance to SOP within Digital our Manufacturing division.
  

Position Qualifications

Education Minimum Requirement:

• High School Diploma required.
  

Required Experience and Skills:

• Minimum of 2 years supporting compliance activities in capital projects.
  
• Extensive experience in the implementation and validation of automation systems such as DeltaV DCS, PLC/SCADA, MES and leading of validation teams.
  
• 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.
  
• 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.
  

Preferred Experience and Skills:

• Post Graduate Qualification in Business Strategy or IT architecture
  
• 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.
  

Travel Requirements:

Travel requirements are 25%. Will be supporting multiple projects at the same time.

Locations are not limited to:

• West Point, PA
  
• Durham, NC
  
• Wilmington, DE
  
• Rahway, NJ
  

Frequent travel for onsite F2F with team members. Travel adjusts based on project needs.

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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 characteristics.--As 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:

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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 another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$77,700.00 - $122,300.00

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 employee's 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 .

You 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:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
25%

Flexible Work Arrangements:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
N/A

Required Skills:
Audit Management, Governance Management, Management Process, Quality Assurance (QA), Quality Management, Risk Management, Task Coordination, Team Management, Technical Advice

-Preferred Skills:

Job Posting End Date:
08/16/2025
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R359201