Senior Validations Engineer

At Kelly® Engineering we’re passionate about helping you find a job that works for you. How about this one?We’re seeking Senior Validations Engineer to work for one of our top Biotechnology Industry client at Juncos, PR. Salary: $45.00 hr - W2Shift: Administrative shift (support a 24/7 manufacturing operations, some remote work is possible)Why you should apply to be Senior Validations EngineerCompetitive pay with biweekly direct deposit (W-2)Hands-on experience supporting critical manufacturing and quality systems in a leading biotechnology environmentCollaborative, fast-paced, and dynamic workplace with growth opportunitiesAccess to extensive training resources and career guidancePaid vacation, sick leave, holidays, and eligibility for a Christmas bonus (Must comply with minimum established requirements to qualify.)This job might be an outstanding fit if you have the following requirements: MS degree in Engineering and 2 years of directly related experience OR BS degree in Engineering and 4 years of directly related experience in pharmaceutical, biotechnology, or other regulated manufacturing industrieExperience leading Commissioning & Qualification (C&Q) strategies, planning, scheduling, and resource management in GMP environments.Strong expertise in FAT, SAT, startup, field commissioning, and IQ/OQ/PQ execution.Knowledge of ASTM E2500, ISPE guidance, risk assessments, and qualification lifecycle management.Experience authoring, reviewing, and approving qualification protocols, validation reports, and technical documentation.Strong understanding of GMP, FDA/EMA regulations, Data Integrity (ALCOA+), Change Controls, Deviations, and CAPA. Experience developing and executing process characterization studies, with strong technical writing, leadership, and project management skills.Proficient in data analysis and strong technical writing skills in English and Spanish.
The Senior Validations Engineer will be responsible for; C&Q Strategy & Planning: Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. Commissioning Activities: Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning. Qualification Execution (IQ/OQ/PQ): Author, review, and approve qualification protocols (IQ, OQ, PQ). Documentation & Compliance: Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal company standards. Risk Management & Change Control: Lead and document risk assessments related to system qualification. Evaluate and manage change controls impacting validated systems. Assess impact of deviations and implement corrective and preventive actions (CAPA). Cross-functional Coordination: Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams. Characterization Process: Develop the characterization protocols. Execute the characterization activities. Develop and review the characterization reports
Helping you discover what’s next in your career is what we’re all about, so let’s get to work.Apply to be Senior Validations Engineer today!Recruiter: Lilly Abouomar #SETTPuertoRico