Validation Lead - Werum PAS-X MES

Overview

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

The Computer System Validation (CSV) Lead will oversee and provide hands‑on validation activities for a Werum PAS‑X 3.1 → 3.4 upgrade. This role will drive a risk‑based validation strategy aligned with GAMP 5 and execute validation deliverables within Kneat (electronic validation platform).

• Lead CSV strategy and execution for PAS‑X upgrade
• Develop and implement a risk‑based validation approach
• Apply GAMP 5 principles to enable a reduced testing strategy
• Author and oversee validation documentation (Validation Plan, Risk Assessment, IQ/OQ, Traceability Matrix, Summary Reports)
• Execute validation activities within Kneat (required)
• Drive deviation management and ensure compliance readiness
• Partner with Technical SME, QA, and IT to ensure seamless execution

• Perform other related duties and assignments as required

• 8+ years of CSV experience in regulated Life Sciences environments
• Direct validation experience with Werum PAS‑X
• Hands‑on Kneat platform experience
• Strong expertise in GAMP 5 methodology
• Proven experience implementing risk‑based and reduced testing strategies
• Experience leading validation efforts through audit and inspection readiness
• Biologics or large‑scale manufacturing experience
• Prior experience with MES upgrades
• Strong stakeholder leadership and communication skills

• Bachelor’s degree in Computer Science or Information Systems or related field
• Master’s Degree preferred

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

USDM Life Sciences is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Salary/Hourly Rate Range (W2): USD 70.00 - 80.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full‑time employees are eligible for health, vision, and dental insurance, life insurance, short and long‑term disability, hospital indemnity, accident, and critical care coverage.

Both full and part‑time employees, who are at least 21 years of age, are eligible to participate in USDM’s 401k plan. Full and part‑time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

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