Werum PAS-X Technical SME - Thousand Oaks - USDM

    USDM
    USDM Thousand Oaks

    12 hours ago

    Description
    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
    The Werum PAS-X Technical SME will support a PAS-X upgrade initiative. This role will provide deep system expertise, hands-on troubleshooting, and technical leadership throughout upgrade execution and testing. Extended involvement supporting Master Batch Records (MBRs) is likely.
    Primary Responsibilities
    • Serve as primary technical SME for PAS-X upgrade
    • Provide hands-on troubleshooting and defect resolution
    • Support configuration, testing execution, and issue remediation
    • Collaborate with validation, QA, IT, and business teams
    • Assist with system impact assessments and technical documentation
    • Support potential Master Batch Record (MBR) design and lifecycle activities
    • Provide consistent onsite support (3 days/week minimum)
    Additional Responsibilities
    • Performs other related duties and assignments as required
    Qualifications
    • 7+ years in regulated Life Sciences environments
    • Deep Werum PAS-X expertise (configuration, upgrades, troubleshooting)
    • Prior experience supporting PAS-X version upgrades
    • Strong understanding of GMP manufacturing systems
    • Ability to support testing and resolve technical defects efficiently
    • Strong communication and stakeholder coordination skills
    • Experience supporting MBR development
    • Prior experience in biologics manufacturing environments
    • Hands-on, solutions-oriented
    • Strong execution under tight timelines
    • Proactive issue identification and resolution
    • Delivers high-quality technical outcomes
    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.
    Disclaimer
    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.
    Compensation
    Salary/Hourly Rate Range (W2): USD
    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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