Validation Specialist V
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The Opportunity
Description
We're looking for a Validation Specialist V, working in Pharmaceuticals and Medical Products industry in 1 Discovery Drive, Swiftwater, Pennsylvania, 18370, United States.- Supports development/validation activities
- Generates development/validation protocols and reports, compile data packs and analyzes data for adherence to established acceptance criteria.
- Develops/validates mixing, filling, formulation, visual inspection and lyophilization.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- BS/MS in Engineering, Life Science or Physical Science
- 5-7 years of experience
- Experience in process validation (formulation, filling, visual inspection and/or lyophilization), performance qualification, E&L, CCIT and Part 4 compliance
- Familiar with Extractables/Leachables
- MS Office 2010, E Doc, Pharmaceutical Validation, Bio Pharma Validation, Validation execution, Technical writing abilities and good time management
- Strong root cause analysis skills with cGMP experience
- Able to establish working relationships with other support and production areas in order to gather all of the necessary information required
- Must be proficient in E Doc with a working knowledge of templates, workflows and approval process
- Proficient in MS Word, Excel, Powerpoint and Outlook
- Interact well with a diverse group of individuals Self-motivated and willing to be proactive in resolving issues
- Excellent Verbal and written communication skills
- Ability to work in a team environment
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
Apply Now
