The Role
Leads Computer System Validation and Computer Software Assurance activities for SAP S/4HANA, SAP Cloud ALM, and related applications in regulated life sciences environments. Develops validation strategies, oversees risk assessments, testing, lifecycle deliverables, and compliance documentation for implementations, upgrades, enhancements, and ongoing support. Partners with Quality, IT, business process owners, and global project teams to ensure data integrity, system reliability, and GxP compliance.
Summary Generated by Built In
This is a remote position.
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role
We are seeking an experienced SAP CSV Lead to provide strategic leadership and oversight for Computer System Validation (CSV) and Computer Software Assurance (CSA) activities supporting SAP S/4HANA and related SAP platforms within regulated Life Sciences environments. This role will partner with Quality, IT, Business Process Owners, and project teams to ensure SAP S/4HANA solutions are implemented, validated, and maintained in compliance with applicable GxP regulations and industry best practices.
This is a part-time (20 hours per week); remote role with occasionally onsite travel required to support project activities. Travel expenses will be reimbursed in accordance with company policy. Candidates must be authorized to work in the United States without current or future sponsorship requirements.
- Lead and oversee CSV and CSA activities for SAP S/4HANA, SAP Cloud ALM, and other related business applications.
- Provide validation leadership throughout SAP S/4HANA implementations, enhancements, upgrades, and ongoing operational support.
- Establish and execute validation strategies that align with regulatory requirements, company procedures, and industry best practices.
- Provide guidance on validation lifecycle deliverables, risk assessments, testing approaches, and compliance documentation.
- Ensure validation activities support data integrity, system reliability, and regulatory compliance objectives.
Requirements
- Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or related discipline.
- 3-6 years of experience supporting and validating SAP S/4HANA environments.
- Significant experience supporting and validating SAP platforms and business-critical enterprise systems.
- Demonstrated experience leading validation efforts for SAP implementations, upgrades, or transformation initiatives.
- Experience utilizing SAP Cloud ALM within validation, testing, or application lifecycle management activities.
- Strong understanding of GxP regulations and computerized system compliance requirements.
- Experience supporting large-scale SAP transformation or digital modernization programs.
- Experience working with global, cross-functional project teams.
- Must be authorized to work in the U.S.
- No C2C at this time.
Benefits
The hourly bracket for this role is set between $40 - $53. The rate offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement
PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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Skills Required
- Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related discipline
- 3-6 years of experience supporting and validating SAP S/4HANA environments
- Significant experience supporting and validating SAP platforms and business-critical enterprise systems
- Experience leading validation efforts for SAP implementations, upgrades, or transformation initiatives
- Experience utilizing SAP Cloud ALM within validation, testing, or application lifecycle management activities
- Strong understanding of GxP regulations and computerized system compliance requirements
- Experience supporting large-scale SAP transformation or digital modernization programs
- Experience working with global, cross-functional project teams
- Must be authorized to work in the United States
- No C2C arrangements
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
