Job Description

**Schedule:** Flexible Monday-Friday (8am-4pm or 9am-5pm) with occasional evening/weekend requirements
**Experience Level:** 2+ years in Biotech/Pharma Validation
**URGENT HIRING NEED**
Join a leading pharmaceutical manufacturing team as a **Validation Specialist** where you'll play a critical role in ensuring product quality and regulatory compliance through comprehensive cleaning and process validation activities.
About This Role
We're seeking a detail-oriented **Validation Specialist** with proven experience in pharmaceutical manufacturing environments. This position offers excellent growth opportunities with a potential contract extension and the convenience of free onsite parking.
Key Responsibilities
Validation & Compliance
- Execute and support **cleaning validation** and **manufacturing process validation** activities
- Ensure strict compliance with regulatory and quality standards (FDA, EMA, ICH guidelines)
- Collaborate cross-functionally with QA, Manufacturing, and Engineering teams
- Support validation lifecycle management from protocol development through execution
Technical Documentation
- Review and author technical documents, SOPs, and validation studies
- Maintain high-quality documentation standards for regulatory submissions
- Conduct thorough document reviews with exceptional attention to detail
- Manage validation documentation and ensure proper version control
Data Management & Analysis
- Utilize **LIMS systems** for data management and reporting
- Analyze validation data and prepare comprehensive reports
- Support deviation investigations and CAPA implementation
- Maintain accurate validation records and databases
Required Qualifications
Education & Experience
- **Bachelor's degree** in Engineering, Science, or related field
- **Minimum 2+ years** of experience in cleaning or manufacturing process validation
- Proven background in **biotech/pharmaceutical** manufacturing environments
Technical Skills
- **Strong technical writing skills** with ability to create clear, concise documentation
- **Proficient in MS Office Suite** (Word, Excel, PowerPoint)
- **LIMS experience** for data management and analysis
- Experience reviewing SOPs, technical documents, and validation studies
Core Competencies
- **Exceptional attention to detail** - critical for regulatory compliance
- Strong analytical and problem-solving abilities
- Excellent communication and collaboration skills
- Ability to work independently and manage multiple priorities
Preferred Qualifications
- **Previous Sanofi experience** - Strong advantage!
- **PI Vision** experience for data visualization and analysis
- Advanced degree in relevant scientific field
- Experience with validation software and electronic systems
- Knowledge of pharmaceutical manufacturing processes
Schedule & Work Environment
Flexible Schedule Options
- **Primary Schedule:** Monday-Friday 8am-4pm or 9am-5pm
- **Occasional Requirements:** Evening shifts (10am-6pm, 11am-7pm)
- **Weekend Work:** May be required based on business needs
- **Flexibility Required:** Schedule adjustments based on production demands
Benefits & Perks
- **Free onsite parking** - No commuting costs!
- **Contract extension potential** - Long-term opportunity
- Collaborative pharmaceutical manufacturing environment
- Exposure to cutting-edge biotech processes
What We're Looking For
The ideal candidate is a **detail-oriented professional** with hands-on pharmaceutical validation experience who can adapt to changing business needs while maintaining the highest quality standards. You should be comfortable working in a fast-paced manufacturing environment and possess strong technical writing capabilities.
Ready to Apply?
If you have pharmaceutical validation experience, strong technical writing skills, and the flexibility to support critical manufacturing operations, we want to hear from you immediately!

Skills Required