60 applicantsPosted by Agency
BioTalent ยท 2 days ago
Validation Engineer
Greater Boston
Full-time
Onsite
Mid Level
4+ years exp
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Hiring Manager
Narissa Moriarty
Insider Connection @BioTalent
Responsibilities
Conduct and document validation projects according to established protocols.
Develop and write validation plans, protocols, and final reports with minimal supervision.
Participate in equipment failure investigations, corrective actions, preventive actions, and equipment release processes. Provide final approval for equipment release.
Offer technical support to less experienced team members.
Communicate effectively with colleagues within and outside the department.
Review and approve validation and calibration documents.
Perform other assigned duties.
Qualification
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Required
Bachelor's degree or equivalent and 4+ years of validation experience, or Master's degree with 2+ years of experience.
Minimum 3 years of experience with process, equipment, utility, or software validation in a GMP environment.
Preferred
Proficiency with data acquisition systems like GE Kaye Validator or ValProbe.
Solid understanding of Good Manufacturing Practices (GMPs).
Excellent written and verbal communication skills.
Basic math and statistical abilities.
Team player with strong interpersonal skills.
Proficient in Microsoft Office Suite (Excel, PowerPoint, Word, Project, Visio).
Familiarity with temperature chamber, sterilization, cleaning, software, and depyrogenation qualifications.
Experience troubleshooting, investigating, and documenting project deviations and discrepancies.
Experience writing validation protocols, project plans, and final reports, and managing validation projects.
Ability to interpret engineering drawings and design documents.
Knowledge of risk management principles.
Awareness of international regulatory requirements.
Company
BioTalent
BioTalent is life sciences recruitment agency with international reach and unrivalled knowledge & expertise.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase
