Katalyst Healthcares & Life Sciences OPT Eligible Jobs USA
Katalyst Healthcares & Life Sciences hires OPT students across consulting, life sciences, and healthcare roles, making it a practical option for F-1 graduates seeking hands-on industry experience. The company's willingness to hire across multiple visa types suggests a structured approach to international talent and a real pathway toward long-term sponsorship.
See All Katalyst Healthcares & Life Sciences JobsOverview
Showing 5 of 107+ Katalyst Healthcares & Life Sciences OPT Eligible Jobs USA
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
See all 107+ Katalyst Healthcares & Life Sciences OPT Eligible Jobs USA
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Katalyst Healthcares & Life Sciences OPT Eligible Jobs USA.
Get Access To All JobsJob Summary:
The CSV Engineer / Validation Engineer will be responsible for ensuring computerized systems in a regulated pharmaceutical environment comply with GxP, 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 9001, and SOX requirements. The role involves supporting validation activities using a risk-based approach aligned with CSA principles, ensuring systems are audit-ready, and maintaining compliance throughout the system lifecycle. The position also requires hands-on involvement in documentation, validation execution, and quality governance for enterprise systems such as Veeva Vault, SAP GxP modules, and LIMS platforms.
Roles & Responsibilities:
- Ensure compliance of computerized systems with regulatory standards including 21 CFR Part 11, GxP, GAMP 5, EU Annex 11, ISO 9001, SOX, and ITIL frameworks.
- Perform audit readiness activities including periodic system reviews, access control evaluations, and audit trail reviews.
- Manage and execute validation lifecycle documentation including URS, FRS, Validation Plans, Protocols (IQ/OQ/PQ), RTM, and Validation Summary Reports.
- Support deviation management, CAPA execution, and change control processes in alignment with SOP and quality policies.
- Apply risk-based validation strategies aligned with CSA (Computer Software Assurance) principles.
- Provide validation support for enterprise systems such as Veeva Vault suite, SAP GxP modules, Labware LIMS, Biovia ELN, and other regulated platforms.
- Collaborate with cross-functional teams in Clinical, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Discovery, and Manufacturing domains.
- Support implementation and validation of RPA GxP bots and AI/ML-based regulatory and manufacturing systems.
- Ensure quality system compliance through documentation review, SOP adherence, and governance activities.
- Contribute to validation of data visualization tools and analytics platforms used in regulated environments.
Education & Experience:
- Bachelor's or Master's degree in Computer Science, Life Sciences, Engineering, Pharmacy, or related field.
- Experience in Computer System Validation (CSV) within pharmaceutical or life sciences regulated environments.
- Strong knowledge of GxP regulations, 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 9001, and SOX compliance requirements.
- Experience with validation of enterprise systems such as Veeva Vault, SAP GxP modules, LIMS, and electronic quality systems.
- Familiarity with risk-based validation approaches and CSA (Computer Software Assurance) methodologies.
- Exposure to validation documentation lifecycle including URS, FRS, IQ/OQ/PQ, RTM, and validation reports.
- Understanding of audit processes, CAPA management, deviation handling, and change control systems.
- Knowledge of pharmaceutical domains such as Clinical, Pharmacovigilance, Regulatory Affairs, Manufacturing, and Medical Affairs is preferred.
- Experience with tools like Veeva Vault, Labware LIMS, SAP, and electronic lab notebooks is an advantage.
Job Summary:
The CSV Engineer / Validation Engineer will be responsible for ensuring computerized systems in a regulated pharmaceutical environment comply with GxP, 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 9001, and SOX requirements. The role involves supporting validation activities using a risk-based approach aligned with CSA principles, ensuring systems are audit-ready, and maintaining compliance throughout the system lifecycle. The position also requires hands-on involvement in documentation, validation execution, and quality governance for enterprise systems such as Veeva Vault, SAP GxP modules, and LIMS platforms.
Roles & Responsibilities:
- Ensure compliance of computerized systems with regulatory standards including 21 CFR Part 11, GxP, GAMP 5, EU Annex 11, ISO 9001, SOX, and ITIL frameworks.
- Perform audit readiness activities including periodic system reviews, access control evaluations, and audit trail reviews.
- Manage and execute validation lifecycle documentation including URS, FRS, Validation Plans, Protocols (IQ/OQ/PQ), RTM, and Validation Summary Reports.
- Support deviation management, CAPA execution, and change control processes in alignment with SOP and quality policies.
- Apply risk-based validation strategies aligned with CSA (Computer Software Assurance) principles.
- Provide validation support for enterprise systems such as Veeva Vault suite, SAP GxP modules, Labware LIMS, Biovia ELN, and other regulated platforms.
- Collaborate with cross-functional teams in Clinical, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Discovery, and Manufacturing domains.
- Support implementation and validation of RPA GxP bots and AI/ML-based regulatory and manufacturing systems.
- Ensure quality system compliance through documentation review, SOP adherence, and governance activities.
- Contribute to validation of data visualization tools and analytics platforms used in regulated environments.
Education & Experience:
- Bachelor's or Master's degree in Computer Science, Life Sciences, Engineering, Pharmacy, or related field.
- Experience in Computer System Validation (CSV) within pharmaceutical or life sciences regulated environments.
- Strong knowledge of GxP regulations, 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 9001, and SOX compliance requirements.
- Experience with validation of enterprise systems such as Veeva Vault, SAP GxP modules, LIMS, and electronic quality systems.
- Familiarity with risk-based validation approaches and CSA (Computer Software Assurance) methodologies.
- Exposure to validation documentation lifecycle including URS, FRS, IQ/OQ/PQ, RTM, and validation reports.
- Understanding of audit processes, CAPA management, deviation handling, and change control systems.
- Knowledge of pharmaceutical domains such as Clinical, Pharmacovigilance, Regulatory Affairs, Manufacturing, and Medical Affairs is preferred.
- Experience with tools like Veeva Vault, Labware LIMS, SAP, and electronic lab notebooks is an advantage.
Job Roles at Katalyst Healthcares & Life Sciences
See all 107+ Katalyst Healthcares & Life Sciences Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Katalyst Healthcares & Life Sciences roles.
Get Access To All JobsTips for Finding Katalyst Healthcares & Life Sciences OPT Eligible Jobs USA
Align your degree to healthcare consulting roles
Katalyst operates at the intersection of life sciences and consulting, so recruiters look for degrees in pharmacy, biotechnology, public health, or biomedical engineering. Map your coursework to their active job categories before applying to strengthen your profile beyond a generic STEM claim.
Confirm E-Verify enrollment before accepting offers
STEM OPT's 24-month extension requires your employer to be enrolled in E-Verify. Ask Katalyst's HR team to confirm enrollment status early in the offer stage, not after you've signed, so you don't lose extension eligibility on a technicality.
Target contract staffing roles for faster OPT placement
Katalyst's staffing model means many openings are client-facing contract roles, which can move faster through the hiring cycle than internal positions. Apply for roles tied to pharmaceutical or clinical clients where project timelines align with your OPT start and end dates.
Use Migrate Mate to identify Katalyst's H-1B filing history
OPT is just the entry point. Use Migrate Mate to review Katalyst's H-1B filing history by occupation code, so you can assess which roles have led to long-term sponsorship and whether the position you're targeting has a realistic conversion path.
Submit your I-983 training plan with specifics
For STEM OPT, your I-983 training plan must describe concrete learning goals, not generic job duties. Reference specific competencies from O*NET for your occupation code and tie them to Katalyst's project deliverables to satisfy USCIS requirements and demonstrate genuine training intent.
Apply before your OPT EAD start date clears
USCIS recommends applying for OPT at least 90 days before your program end date. Submit your application to your DSO well in advance, since Katalyst's HR won't extend start dates for candidates whose EAD hasn't arrived, and onboarding delays can cost you the role.
Katalyst Healthcares & Life Sciences OPT Eligibility: Frequently Asked Questions
Does Katalyst Healthcares & Life Sciences sponsor OPT visas?
Katalyst Healthcares & Life Sciences hires F-1 students who already hold an OPT EAD. OPT authorization comes from USCIS, not from Katalyst. What the company provides is employment in qualifying roles, E-Verify enrollment for STEM OPT eligibility, and a documented training environment required for the 24-month STEM OPT extension.
Which roles at Katalyst Healthcares & Life Sciences typically hire OPT students?
Katalyst most commonly places OPT students in life sciences consulting, clinical operations, regulatory affairs, and healthcare IT roles. Their staffing model means openings span both direct placements and client-site contract positions across pharmaceutical, biotech, and healthcare organizations, which broadens the types of roles available to OPT candidates.
How do I apply for OPT jobs at Katalyst Healthcares & Life Sciences?
Apply directly through Katalyst's careers page and specify your OPT authorization type and EAD expiration date in your application. Recruiters screen for candidates whose OPT window aligns with project timelines, so being clear about your start date availability and STEM extension eligibility upfront avoids delays in the screening process.
How do I know if Katalyst Healthcares & Life Sciences will sponsor my H-1B after OPT?
H-1B visa sponsorship is a separate decision from OPT hiring. Use Migrate Mate to review Katalyst's H-1B visa Labor Condition Application filing history by occupation code, which shows which roles have historically led to H-1B sponsorship. This gives you a clearer picture of long-term sponsorship likelihood before accepting an OPT offer.
What should I prepare before interviewing for an OPT role at Katalyst Healthcares & Life Sciences?
Have your I-20 with OPT authorization, your EAD card or receipt notice, and a clear explanation of your STEM OPT eligibility ready before your first interview. Katalyst's consulting clients often require candidates to be deployable quickly, so demonstrating that your work authorization paperwork is complete removes a common hiring barrier.
How does Katalyst Healthcares & Life Sciences hire OPT students?
OPT is work authorization granted directly to F-1 students after graduation — no employer petition is required. Katalyst Healthcares & Life Sciences can hire OPT students as soon as their EAD card is approved. STEM degree holders can extend OPT by 24 months when their employer is enrolled in E-Verify. Most companies that hire OPT students also support the transition to H-1B when the student's OPT period is ending. Check Katalyst Healthcares & Life Sciences's individual postings on Migrate Mate to confirm OPT acceptance per role.