Validation Specialist
2 days ago
The Validation Engineer will be accountable for supporting validation activities and validation change management system for validated equipment, utilities, and facilities at Planet Pharma.
Key Responsibilities:
- Support the development, execution, and management of timelines for CA/SIA/RTM/DIA/URS activities.
- Track and trend activities, reporting on issues affecting predetermined timelines and problems as needed.
- Support validation activities, coordinating 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 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.
- Foster an environment that encourages continuous learning, maintaining expertise to stay abreast of technical and industry advancements.
Qualifications / Requirements:
- BS in chemical, biochemical engineering, or related field/experience, with a minimum of 2 years experience in process engineering, validation engineering, or Technical Services is required.
- Strong technical writing skills.
- Cleaning and Sterilization qualification experience is a must.
- Experience in the pharma/biotech industry is a plus, with knowledge of cGMPs or equivalent regulations.
- 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.
- Operational excellence and industrial engineering skills are a plus.
- Professional level written and oral communication skills.
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