Full-Time
Validation Engineer 3
Artech Information System
1,001-5,000 employees
IT staffing and project-based workforce solutions
No salary listed
Framingham, MA, USA
In Person
 QA & Testing (1) |
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- Bachelor's degree with 6-9 years in biopharmaceuticals or Life Sciences OR Master's degree with 4-7 years in biopharmaceuticals or Life Sciences
- 2 years experience working in cGMP environment
- Excellent writing and editing skills and must write in a concise and easy-to-read manner
- Proficient with MS Office Applications
- Experience with HPLC, Dionex, GC, LCMS, UVVis Spectroscopy and empower software
- Familiarity with 21CFR part 11 validation automation systems is required
- Ensure cGXP compliance in all documentation
- Document Laboratory Equipment Qualification / Validation studies, specifically pertaining to Quality Control
- Prepare drafts of the protocol and technical report documentation for review with subject matter experts, project staff and/or customers
- Edit, standardize, or revise material prepared by other writers or subject matter experts
- Create and revise protocols and technical reports for Laboratory Equipment Qualification (IQ, OQ, and PQ) with input from subject matter experts and according to company policies
- Assist multiple teams of technical experts in the technical writing of Laboratory Equipment Qualification
- Prepare binders containing all relevant documentation. Organize documentation and cross-reference documents as necessary
- Route final documents for the appropriate approvals
- Revisions of Laboratory Equipment Qualification documentation must be done utilizing defined content and formatting requirements. Ensure cGXP compliance in all documentation
- Investigate and document non-conformances in a timely manner
- Able train on and follow company SOP documentation standards, templates and practices
- Work in compliance with cGMPs
- Incorporate new material or information while understanding its implications
- Work independently under minimal supervision and direction
- Work effectively across organizational and functional boundaries
- None
Artech Information System provides IT staffing and project-based services worldwide. It connects organizations with tech talent through staffing programs (contingent, direct hire, RPO, master vendor, payroll transition) and delivers end-to-end digital and technical projects (design, operations, development, and platforms). It stands out through its focus on applied human intelligence, diverse and inclusive culture, and a track record with Fortune 500 clients across multiple countries. Its goal is to be the ecosystem that connects people, technology, and opportunities, enabling global businesses and talent to grow together.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Morristown, New Jersey
Founded
1992
Simplify's Take
What believers are saying
- Artech provides managed cloud and cybersecurity services to Fortune 500 firms.
- Artech supports public-sector organizations amid AI and cloud shifts.
- Artech generated over $775 million in global revenue as women-owned business.
What critics are saying
- Trump's 2025 H-1B tightening cuts Artech's India staffing in 3-6 months.
- Apex Group acquisitions erode Artech's position in 12-24 months.
- 2026 recession freezes Fortune 500 IT budgets, hitting Artech revenue.
What makes Artech Information System unique
- Artech is the largest women-owned IT workforce solutions firm in the U.S.
- Artech holds Great Place to Work certification for its dynamic culture.
- Artech expanded India offices in Bengaluru, Bhopal, Hyderabad, and Chennai.
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Benefits
Remote Work Options