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