Benjamin Long
Service Delivery Manager - Principal Validation Engineer
Schoolcraft,MI
Summary
Collaborative validation leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings. A proficient quality and validation professional with over 7 years of experience with industry leading pharmaceutical and medical device companies to implement new equipment and facility work centers, as well as upgrading existing equipment. Specific areas of expertise include Supervisory Controls and Data Acquisition (SCADA) and Programmable Logic Controllers (PLC), injectable filling equipment, seal strength integrity testing, facilities and airflow qualification, quality tracking systems, engineering change control, and risk assessment and management.
Overview
11
11
years of professional experience
5
5
years of post-secondary education
6
6
Certifications
Work History
Service Delivery Manager/Principal Validation Eng.
Performance Validation, Inc.
Portage, MI
04.2024 - Current
- Established culture of continuous improvement, encouraging team members to share ideas for process enhancements.
- Led cross-functional teams to achieve project goals on time and within budget.
- Reduced turnaround time with effective resource allocation and task prioritization.
- Ensured regulatory compliance with FDA guidelines by conducting thorough validations and maintaining accurate documentation.
- Evaluated change control requests to assess potential impacts on validated systems, ensuring ongoing compliance with regulations.
- Provided technical expertise during design phase of new equipment installation projects increasing efficiency.
- Managed multiple validation projects simultaneously while adhering to strict deadlines and budget constraints.
Project Lead / Internal Auditor
Performance Validation
Portage, MI
01.2020 - Current
- Maintained tactical control of project budgets and timelines to keep teams on task and achieve schedule targets.
- Produced quality standards, checklists, report templates, and processes.
- Met with project manager weekly to provide detailed project report and milestone updates.
- Partnered with project team members to identify and quickly address problems.
- Developed and trained junior team members by leveraging industry experience to achieve optimal project strategy.
- Verified quality of deliverables and conformance to specifications before submitting to clients.
Site Manager: Pharmaceutical Facilities
Performance Validation
Portage, MI
01.2022 - 03.2024
- Complied with safe operating practices and assessed operational procedures against best practices.
- Oversaw all daily office operations and service deliverables.
- Created monthly reports and presentations for senior management team.
- Monitored, coached, and supervised team of 14 employees in 2023.
- Assumed responsibility for personnel deployed to work site.
- Resolved issues between employees and customers using company policies.
- Managed change orders effectively, minimizing disruptions to project timelines and ensuring client satisfaction through prompt resolution of issues.
Senior Validation Engineer
Performance Validation Inc
Portage, MI
05.2017 - 03.2024
- Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity and other factors.
- Participated in system design and commissioning phase, interfacing directly with clients to ascertain clear, concise milestones for integration into development timelines.
- Authored validation protocols for Pharmaceutical injectable manufacturing systems (sterilization, manufacturing, sterile filling, qualified utilities, controls systems, etc.) verifying compliance with internal policies, client user requirements and equipment specifications.
- Collaborated on Standard Operating Procedure (SOP) development, incorporating input from matrixed project teams to reduce liability and enhance successful deployments.
- Worked closely with different departments to develop innovative solutions to functionality issues.
- Analyzed pre-release software titles for compliance with User Requirement Specifications (URS), referring any deficits to appropriate personnel.
- Wrote and optimized test cases for four concurrent wokcenter projects to maximize success of manual software testing with consistent, thorough approaches.
Material Systems Specialist: Injection Molding
Summit Polymers Inc: Technical Center
Portage, MI
05.2015 - 05.2017
- Collected data on process control statistics to discover potential improvements to process capabilities.
- Set system metrics and thresholds to maintain proper operational continuity.
- Collaborated with stakeholders to enhance injection molding system utilization and efficiency by customizing business forecasting processes, increasing forecasting accuracy by 15%.
- Updated and maintained supply chain capacity records in accordance with customer requirements.
Orthopedic Hip Regulatory Co-op
Zimmer Biomet
Warsaw, IN
01.2013 - 08.2014
- Developed client reports and other correspondence.
- Used spreadsheets, databases and other resources to produce client deliverables.
- Maintained database systems to track and analyze regulatory data.
- Gathered, organized and input information into digital database.
Education
Bachelor of Science - Bioengineering, Chemistry
University of Toledo
Toledo, OH 08.2010 - 05.2015
Skills
OSHA compliance
Procedures development
Estimating
Design and planning
Proficient in QTS Trackwise
Project Management
Management
Industry standard knowledge (FDA CFR 21 Parts 11,210, 211, 820 and ISO 13485)
Effective communication
Quality monitoring
Operations Support
Certification
ASQ Certified Quality Auditor CQA (2022)
Affiliations
American Society for Quality (ASQ)
International Society for Pharmaceutical Engineering (ISPE)
Timeline
Service Delivery Manager/Principal Validation Eng.
Performance Validation, Inc.
04.2024 - Current
Site Manager: Pharmaceutical Facilities
Performance Validation
01.2022 - 03.2024
Project Lead / Internal Auditor
Performance Validation
01.2020 - Current
Senior Validation Engineer
Performance Validation Inc
05.2017 - 03.2024
Material Systems Specialist: Injection Molding
Summit Polymers Inc: Technical Center
05.2015 - 05.2017
Orthopedic Hip Regulatory Co-op
Zimmer Biomet
01.2013 - 08.2014
Bachelor of Science - Bioengineering, Chemistry
University of Toledo
08.2010 - 05.2015