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 sets 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
USDM Life Sciences is seeking an SAP Validation consultant for a long-term project.
- Supports internal and external audits of electronic systems to verify that systems are validated and maintained in a validated state in accordance with standards and regulatory requirements such as 21 CFR Part 11, Annex 11, ICH E6 R2, OECD Advisory Document 17, applicable Predicate Rules, etc.
- Provide compliance support for the validation and maintenance of electronic systems in accordance with computer system validation (CSV) procedures and regulatory requirements.
- Review and approve CSV deliverables such as Validation Plans, Requirements, Test Scripts, Trace Matrices, Validation Summary Report, etc. associated with the validation and maintenance of computerized systems
- Support updates to management on projects, health of the CSV process and communicate risk-based escalation issues, when applicable.
- Support resolution of CSV deviations/errors and provide compliance oversight to software validation projects.
- Support the development of training materials, related to the validation of GxP computer systems and/or the use or administration of validated systems. Works closely with IT and software/system vendor(s) as needed, to ensure user/design materials and test documentation can be leveraged and is acceptable.
- Supports the interpretation of CSV regulations, guidelines and GxP practices and meets regulatory compliance and corporate business requirements.
- Liaises with IT and other cross-functional business teams to ensure that electronic systems for issue management and general IT compliance support.
- Must have SAP experience, HPALM is nice to have but not required.
- At least 3 years of experience in a pharmaceutical, biotechnology or related environment combined, with at least 3 years of experience in audits and oversight of GxP Computer System validation or equivalent experience and/or education.
- Demonstrated, hands-on, applied knowledge and understanding of applicable GxP or regulatory authority regulations and guidances related to CSV (such as, GCP, GPvP, GLP, GMP, GAMP, Part 11, Annex 11, ICH E6, OECD, etc.) activities and compliance.
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Knowledge of word-processing, spreadsheet, and database applications.
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- Considerable knowledge of quality assurance processes and procedures.
- Strong interpersonal skills.
Education & Certifications
- Bachelor’s degree in technical, scientific or other relevant academic discipline.
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:
- Sit or stand at a desk in an environmentally controlled home office environment for prolonged periods of time.
- Constantly operate a computer and 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.
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.
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