Under the direction of the PLANT Tech Transfer Validation Lead, the Validation Engineer will be accountable for supporting validation activities and validation change management system for validated equipment, utilities and facilities such as Critical Assessment (CA), System Impact Assessment (SIA), Requirements Trace Matrix (RTM), Data Integrity Assessment (DIA), User Requirements (URS) and protocol generations relevant to validation activities.
Responsibilities:
Support the development, execution, and management of the timelines for the execution of CA/SIA/RTM/DIA/URS activities.
Track and trend activities and report on issues such as impact to predetermined timelines and problems as needed.
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 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. Maintain expertise as necessary 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. No more than 2-5 years of exp. needed.
Strong in Technical Writing.
Cleaning and Sterilization qualification experience is a must.
Experience in the pharma/biotech industry is a plus. 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.