Department: Azzur of NE, LLC
Essential Duties and Responsibilities:
- Development and editing of technical documentation including:
- Standard Operating Procedures
- User Requirements and Design Specifications
- Commissioning and Qualification Protocols
- Validation Summary Reports
- Execution of validation protocols
- Deviations, CAPA and Change Management
- Thermal mapping of Control Temperature Units and SIP processes
- Data Analysis and Technical report writing
- Performs/executes/validation/verification studies (FAT, SAT, CTP, IQ, OQ, PQ) for cleaning, sterilization, equipment, systems, utilities, and processes for qualification/verification and/or re-qualification/re-verification.
- BS in Engineering, Science or equivalent technical degree.
- 0-2 years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Strong written and verbal communication skills; excellent technical writing skills.
- Ability to work effectively in a fast-paced team environment.
- Working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.
- Ability to travel to client sites throughout the New England region.
Who we are:
Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, and consulting services. At Azzur, we look to hire full-time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments. Using our 4 Core Values as guidance, we expect all Azzur Employees to:
- Put Others First,
- Have the Courage to Take Action,
- Take Personal Responsibility, and
- Have Fun!
Azzur can offer you:
- Flexible PTO Policy
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Company provided laptop
If you can deliver high-quality customer service and results while engaging in our fun and energetic culture; we want to hear from you!