Validation Engineering Specialist
3 weeks ago
We are seeking a highly skilled Validation Engineering Specialist to join our team at Avispa Technology. The successful candidate will be accountable for supporting validation activities and validation change management system for validated equipment, utilities, and facilities.
About the RoleThe ideal candidate will have two to five years of experience in process engineering, validation engineering, or technical services. You will support the development, execution, and management of timelines for CA/SIA/RTM/DIA/URS activities, track and trend activities, and report on issues as needed.
Responsibilities- Support validation activities and coordinate the collection, testing, and analysis of samples and reporting of results required per validation protocol.
- Support the change management system for validated equipment, utilities, and facilities.
- Assist with the preparation and review of relevant sections of protocol generations/approvals processes.
- Serve as a representative on cross-functional and multi-site teams.
- Support development of formulation, filling, and packaging area SOPs and manufacturing documents as appropriate.
- 2-5 years of experience in process engineering, validation engineering, or technical services.
- BS in chemical, biochemical engineering, or related field/experience.
- Cleaning and Sterilization qualification experience.
- Experience in the pharma/biotech industry is a plus.
- Knowledge of cGMPs or equivalent regulations.
- Strong in Technical Writing.
- Working knowledge of formulation, filling, inspection, and packaging equipment qualification in a regulated environment.
- Demonstrated understanding of project management skills.
- Ability to work with internal teams, partners, suppliers, and customers.
- Hourly pay: $35-$45/hr.
- W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL.
- 40 hours/week, 10 Month Assignment.
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