USDM Life Sciences

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 CSV Lead owns the risk-based validation strategy, deliverable approval, and release governance for the GxP computerized systems supporting a greenfield clinical biologics drug substance facility in Foster City. The role serves as the Validation Lead and validation approver for a new DeltaV process control system, a new PAS-X manufacturing execution system, and a process knowledge management platform supporting technical transfer.
Primary Responsibilities
<ul>
<li>Serve as the designated Validation Lead and CSV approver for all validation deliverables, including validation plans, specifications, risk assessments, traceability matrices, qualification protocols, discrepancies, and validation summary reports.</li>
<li>Own the risk-based validation strategy in alignment with GAMP 5, Computer Software Assurance, 21 CFR Part 11, EU GMP Annex 11, data integrity/ALCOA+ expectations, and Client CSV procedures.</li>
<li>Own software categorization and configured library reuse decisions for the process control system, and determine with documented justification where supplier qualification, integrator FAT/SAT, and prior-deployment evidence may be leveraged within the risk-based testing strategy.</li>
<li>Define the qualification approach for the DeltaV PCSD library, leveraging Emerson-provided standard library documentation and testing evidence for unmodified module classes, and requiring documented design, impact assessment, and risk-based testing for Client-modified or custom library objects, with library version control maintained under change control.</li>
<li>Participate in requirements, design, and risk assessment workshops, and govern change control and change impact/regression assessments so the validated state is maintained throughout implementation.</li>
<li>Define and approve the integration qualification approach for data flows across process control, manufacturing execution, laboratory, and enterprise systems, and sequence integration testing against equipment availability and project milestones.</li>
<li>Make and document release-readiness decisions, ensuring qualification evidence, open discrepancies, periodic review status, and training status support GMP use.</li>
<li>Maintain alignment to the integrated project schedule, coordinate with the CQV workstream so CSV and equipment qualification activities are sequenced correctly, and escalate validation risks and schedule impacts to project leadership.</li>
<li>Partner with Quality Assurance, Automation, Engineering, IT/OT Infrastructure, Manufacturing, System Owners, and service providers to resolve validation issues, and sustain validation ownership after go-live through periodic review and change control.</li>
</ul>
Additional Responsibilities
<ul>
<li>Performs other related duties and assignments as required</li>
</ul>
Required Qualifications
<ul>
<li>Demonstrated experience as a Validation Lead and approver for GxP computerized systems through a full validation lifecycle, including greenfield or major capital projects.</li>
<li>Hands-on validation experience with DeltaV or comparable distributed control systems in GMP biologics manufacturing, including batch, recipe, phase, and ISA-88 library qualification, and qualification of standard (e.g., Emerson PCSD) versus site-modified libraries.</li>
<li>Experience validating a manufacturing execution system, including electronic batch records, master batch record and recipe qualification, and review by exception.</li>
<li>Working knowledge of GAMP 5, Computer Software Assurance, 21 CFR Part 11, EU GMP Annex 11, and data integrity/ALCOA+ principles, with practical experience applying risk-based testing and supplier leverage.</li>
<li>Experience authoring, reviewing, and approving the full CSV deliverable set: validation plans, URS, FRS, design/configuration specifications, risk assessments, traceability matrices, IQ/OQ/PQ protocols, discrepancies, and validation summary reports.</li>
<li>Experience with electronic validation/document management platforms (Kneat, ValGenesis, or equivalent) and GMP change control systems.</li>
<li>Strong written and verbal communication skills, with the ability to drive decisions across Quality, Automation, IT/OT, Engineering, and Manufacturing.</li>
</ul>
Preferred Qualifications
<ul>
<li>Experience validating knowledge management, recipe management, or technical transfer platforms.</li>
<li>Experience defining and defending supplier leverage strategies with Quality, including vendor validation assessments and testing gap assessments.</li>
<li>Experience validating integrations across control, execution, and enterprise layers, including end-to-end testing across system boundaries.</li>
<li>Experience qualifying cloud-hosted or SaaS-delivered GxP systems, including hosting model evaluation.</li>
</ul>
Education &amp; Certifications
<ul>
<li>Bachelor's degree in engineering, Computer Science, Life Sciences, or a related technical discipline, with 15+ years of CSV experience in a GMP-regulated biopharmaceutical environment.</li>
</ul>
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:
<ul>
<li>Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.</li>
<li>Operate other office productivity machinery, such as a calculator, scanner, or printer.</li>
<li>Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.</li>
</ul>
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 85.00 - 100.00
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.
For more details about our benefits, visit us here: <a href="https://usdm.com/careers" rel="nofollow noopener" target="_blank">https://usdm.com/careers</a>

CSV Lead – DeltaV PCS, MES and PKM

CSV Lead – DeltaV PCS, MES and PKM

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