Validation Engineer - Werum PAS-X (Korber) (PST workers only)

Job Title

Validation Resource for PAS-X Upgrade Project

About USDM

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.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

Seeking a validation resource to support a PAS-X upgrade project. On-site in southern CA preferred, if not, remote in PST would work, not open to remote workers on EST/CST/MST.

Primary Responsibilities

• Support execution of validation activities for the PAS-X upgrade program under the direction of the lead validation resource.
• Work within an electronic validation approach leveraging Kneat.
• Apply GAMP 5 principles and regulated-system validation practices throughout planning, execution, and documentation.
• Provide backup coverage to Lead and help the team move through the project faster by adding validation bandwidth.
• Contribute to validation deliverables associated with the PAS-X upgrade and related implementation workstreams.

Additional Responsibilities

• Performs other related duties and assignments as required

Qualifications

• Hands-on computer system validation experience in regulated GxP environments.
• Prior experience with Kneat electronic validation workflows.
• Working knowledge of GAMP 5 and risk-based validation execution.
• Experience supporting manufacturing system upgrades, ideally involving PAS-X / Körber.
• Validation experience supporting MES / PAS-X programs in biopharma manufacturing.
• Ability to work effectively in a fast-moving contract environment where scope has shifted from PM/SME-heavy coverage toward additional validation throughput.

Education & Certifications

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

Working Conditions

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.

Equal Opportunity Statement

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.

Compensation

Salary/Hourly Rate Range (W2): USD 75.00 - 85.00

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.