Sean Sullivan
Senior Validation Engineer
Flowery Branch,GA
Summary
Offering strong foundation in engineering principles and passion for learning and developing in technical environment. Brings solid understanding of quality control and regulatory compliance, along with skills in data analysis and process validation. Ready to use and develop analytical skills and quality assurance expertise in [Desired Position] role.
Knowledgeable [Desired Position] with proven track record in validation processes and compliance protocols. Successfully led multiple validation projects, ensuring adherence to industry standards and regulatory requirements. Demonstrated expertise in risk assessment and quality assurance, showcasing strong analytical and problem-solving skills.
Overview
23
23
years of professional experience
6
6
Certifications
4
4
years of post-secondary education
Work History
Client Manager
CAI
06.2021 - Current
- Built client relationships by responding to inquiries, identifying and assessing clients' needs, resolving problems, and following up with potential and existing clients.
- Handled complaints, provided appropriate solutions, and alternatives within appropriate timeframes and followed up to achieve resolution.
- Performed duties and provided service in accordance with established operating procedures and company policies.
- Organized daily workflow and assessed appropriate staffing to provide optimal service.
- Developed new employees and on-going performance assessment of current employees.
- Collaborated with finance department on invoicing accuracy for applicable products, services, software, and logistics.
- Partnered with business leaders to deliver services that support company objectives and consistent with corporate values.
- Led team meetings focused on continuous improvement, fostering an environment of open dialogue and constructive feedback among team members.
- Collaborated with cross-functional teams to identify opportunities for growth and expansion of services offered.
- Delivered exceptional customer service by proactively anticipating client needs and providing tailored solutions.
- Trained new employees on company policies, procedures, and best practices, ensuring seamless integration into the team dynamic.
- Actively participated in industry conferences, networking events, and professional development opportunities to stay current on trends relevant to our clientele.
- Managed accounts to retain existing relationships and grow share of business.
- Maintained financial controls, planned business operations and control expenses while identifying and pursuing opportunities to grow business operations and boost profits.
Senior Validation Engineer
CAI
02.2014 - Current
- Authored validation protocols for multiple pharmaceutical and medical device systems, verifying compliance with internal policies and external best practices.
- Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors.
- Collaborated on Standard Operating Procedure (SOP) development, incorporating input from system owners to reduce liability and enhance successful deployments.
- Generated validation plans for a myriad of projects types, setting specific temporal and budgetary goals for development and delivery.
- Played a key role in addressing audit findings related to equipment qualifications, ensuring corrective actions were implemented promptly and effectively.
- Improved validation processes by implementing risk-based strategies and best practices.
- Mentored junior engineers, providing guidance on best practices in validation engineering and fostering professional growth.
- Developed and maintained comprehensive validation documentation, ensuring compliance with industry standards and regulations.
- Assessed current validation methods, recommending improvements to streamline processes while maintaining quality standards.
- Performed detailed reviews of validation reports, identifying potential gaps or inconsistencies that could impact product quality or compliance.
- Collaborated with cross-functional teams to develop robust test protocols and methodologies for new product introduction.
- Optimized validation schedules by prioritizing critical projects based on business needs and resource availability.
- Reduced overall project timelines through effective coordination of resources and efficient execution of validation activities.
- Reviewed requirements, specifications, and technical design documents to provide timely and meaningful feedback.
- Participated in available trainings to improve software knowledge.
- Met tight deadlines to satisfy client demands and project timelines.
- Collaborated with cross-functional teams for identification and resolution of validation issues.
- Developed validation master plans, process flow diagrams and standard operating procedures.
Nuclear Machinist Mate Supervisor
Navy
03.2007 - 04.2014
- Contributed to the development of departmental policies and procedures, ensuring alignment with organizational goals and regulatory requirements.
- Reduced equipment downtime by conducting preventive maintenance and system evaluations, ensuring optimal functionality.
- Maintained accurate documentation of work performed, adhering to strict regulatory guidelines and facilitating audits when necessary.
- Managed personnel schedules, allocating resources effectively to minimize gaps in coverage and maintain smooth operations.
- Provided technical expertise during troubleshooting efforts, diagnosing complex issues quickly to minimize disruptions to operations.
- Mentored junior staff members, fostering a collaborative environment conducive to learning new skills and advancing career growth opportunities.
- Facilitated cross-training initiatives among team members, increasing overall knowledge base within the department while also enhancing workforce flexibility.
- Ensured timely completion of projects by closely monitoring progress and adjusting resources accordingly throughout each phase of execution.
- Improved safety compliance by enforcing adherence to established protocols and regularly providing refresher training sessions for staff members.
- Inspected, repaired and replaced system components.
- Read and interpreted technical documentation.
- Created and maintained daily and weekly reports for upper management.
- Scheduled and oversaw maintenance, repair and installation activities.
- Utilized proper tools and materials to adhere to safety guidelines.
- Monitored priorities and liaised between maintenance team and management, delegating tasks to complete on time.
- Contributed to development, implementation, and execution of maintenance programs.
- Kept watchful eye on equipment inventories, optimizing work readiness and aligning supplies with specifications for each job.
- Reviewed and studied blueprints to double-check installation and implementation project requirements.
- Shrunk knowledge gaps with ongoing training and close employee mentoring for new and less experienced team members.
Radiological Controls Supervisor
Navy
05.2007 - 09.2010
- Enhanced radiological safety by implementing effective controls and monitoring procedures.
- Ensured compliance by staying up-to-date on regulations and applying them consistently in the workplace.
- Coordinated asset inventory efforts to track radioactive materials accurately throughout their lifecycle within the facility.
- Reduced exposure risks by conducting thorough radiation surveys and maintaining accurate documentation.
- Provided technical support during maintenance activities involving radioactive systems, minimizing downtime while maintaining safety standards.
- Maintained a safe work environment by enforcing strict adherence to radiological safety guidelines among employees.
- Collaborated with engineers to design shielding solutions, reducing worker exposure during high-radiation activities.
- Educated staff on the importance of radiation protection principles and best practices, fostering a culture of safety and responsibility in the workplace.
- Led drills simulating radiological emergencies to test preparedness levels within the organization, refining response strategies based on lessons learned.
- Assessed employee performance through regular evaluations against established radiological safety criteria, providing constructive feedback for improvement.
- Improved team efficiency with comprehensive training programs for Radiological Control Technicians.
- Optimized emergency response plans, ensuring rapid containment and mitigation of potential radiological incidents.
- Managed radiological waste disposal, minimizing environmental impact and adhering to regulatory requirements.
- Managed maintenance of systems and facilities handling fluid from nuclear reactor operations.
Nuclear Machinist Mate
Navy
11.2001 - 05.2007
- Inspected, repaired and replaced system components.
- Minimized equipment wear by performing precise alignments on rotating machinery using alignment tools and dial indicators.
- Maintained peak performance of nuclear machinery with consistent preventive maintenance and repairs.
- Safeguarded personnel by enforcing strict adherence to radiation protection guidelines during operations.
- Contributed to successful plant shutdowns, orchestrating detailed procedures for equipment isolation and decontamination.
- Facilitated knowledge transfer among team members by providing expert guidance on technical matters related to nuclear propulsion systems.
- Conducted extensive valve maintenance for optimal flow control within steam generation systems, contributing to improved heat transfer rates between primary coolant loops and steam generators.
- Ensured regulatory compliance by maintaining accurate records of routine checks, tests, and corrective actions taken.
- Improved system reliability through comprehensive testing and troubleshooting of nuclear components.
- Collaborated effectively with interdisciplinary teams to optimize plant performance and address complex issues.
- Read and interpreted technical documentation.
- Determined strategies for controlling radiation exposure and limiting overall risks.
- Started, stopped, adjusted, tested and operated pumps, valves, switchgears and system controls to keep operations within tight tolerances.
- Maintained open and effective communication systems by dispatching orders and instructions to personnel through radiotelephone and intercommunication systems.
- Followed nuclear equipment operational policies and procedures to drive environmental safety.
- Identified and documented radiation found in facility areas and on tools, equipment and instrumentation.
- Recorded operating data and results of surveillance tests in permanent internal and records accessible by auditors and regulatory agencies.
- Monitored nuclear reactor equipment performance to identify operational inefficiencies, hazards or needs for maintenance or repair.
- Followed nuclear equipment operational policies and procedures to promote environmental safety.
Education
Bachelor of Science - Nuclear Engineering Technologies
Thomas Edison State University
Trenton, NJ 02.2023 - Current
Associate of Science - Nuclear Engineering Technologies
Thomas Edison State University
Trenton, NJ 02.2023 - 09.2024
High School Diploma -
Olympic Heights Community High School
Boca Raton, FL 05.2001 -
Skills
Client services
Affiliations
- International Society for Pharmaceutical Engineering
- Georgia Bio
- Bio Alabama
- The American Legion
- Veterans of Foreign Wars
- United States Submarine Veterans, Inc.
- Boy Scouts of America
Certification
CPVP - Certified Process Validation Professional
Timeline
NFPA70E Qualified Person
02-2024
OSHA 30-Hour Construction
02-2024
Bachelor of Science - Nuclear Engineering Technologies
Thomas Edison State University
02.2023 - Current
Associate of Science - Nuclear Engineering Technologies
Thomas Edison State University
02.2023 - 09.2024
Client Manager
CAI
06.2021 - Current
Lean Six Sigma Green Belt
08-2019
CPVP - Certified Process Validation Professional
06-2017
Senior Validation Engineer
CAI
02.2014 - Current
OSHA 10-Hour
02-2014
Radiological Controls Supervisor
Navy
05.2007 - 09.2010
Nuclear Machinist Mate Supervisor
Navy
03.2007 - 04.2014
EPA Refrigerant Technician Universal Certification
08-2005
Nuclear Machinist Mate
Navy
11.2001 - 05.2007
High School Diploma -
Olympic Heights Community High School
05.2001 -
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