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Client Development Lead, Validation and Regulatory Compliance
Bw Design Group
Leading a Validation and Regulatory Compliance team for pharmaceutical, biotech, and medical device manufacturing projects.
19d ago
$160,000 - $230,000
Expert & Leadership (13+ years), Experienced (8-12 years)
Full Time
Irvine, CA
Office Full-Time
Company Size
2,000 Employees
Service Specialisms
Consulting
Engineering
Architecture
Design
Sector Specialisms
Food & Beverage
Life Sciences
Advanced Technology
Industrial
Chemicals & Plastics
Household & Personal Care
Metals
Semiconductor & Electronics
Role
What you would be doing
material research
industry engagement
client relationships
process improvement
integrated solutions
client meetings
- Research material options to deliver an optimal solution for the client when required by project scope
- Participate actively in relevant industry organization events and conferences
- Build and sustain long term client and internal relationships
- Innovate and improve design and service delivery method and processes
- Create integrated solutions and communicate key concepts to the client
- Meet with clients to define the program requirements based on an understanding of the client's production process flow and space environmental needs derived from meetings with the client and the review of any documentation provided by the client
- Travel as required for client development and project execution
- Assign and review work of project team.
- Check progress of work and alert project leads to change of scope or additional services.
- Develop the base plan and coordinate technical requirements with engineering disciplines
- Understand and develop design intent based on client objectives and provide excellent client service
- Prepare or review budgets based on experience and scope of project.
- Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team
- Assess the requirements of a project, break a project into tasks, and work with teams to determine scope of work, budget and staffing
- Assist in the education and development of the team and act as resource for questions.
What you bring
project management
life science
fda validation
leadership
communication
process automation
- Coordinate all aspects of project document completion within company and externally with clients and other design professionals. Proficient written and oral communications skills.
- Experience building, managing, and leading teams
- Strong leadership, verbal communication, technical writing, project management tools and word processing skills.
- Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.
- Communicate and interact directly with clients in a collaborative and professional manner
- Demonstrated client development experience and excellent presentation skills
- Project Management experience in managing scope, cost, schedule, quality and risk is required.
- 15+ years of Life Science operational & engineering experience in the pharmaceutical, biotech or medical device sectors - Client side & Consulting experience highly preferred
- Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.
- Experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
- Experience with creating proposals and business development.
- Excellent time management skills and ability to multi-task on simultaneous projects
- Diverse experience in leading CQV project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation is desirable.
- 10+ years’ experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects
- Displayed leadership in a consulting and service environment.
- Display enthusiasm and excitement for client projects that lifts project teams to high levels of job satisfaction
- Experience with financial systems, project, and client administration
- BS Degree in Engineering or related technical degree
Information not given or found
Training + DevelopmentInformation not given or found
Interview process
Information not given or found
Visa SponsorshipInformation not given or found
Security clearance- employment verification
- background screening
- skills assessments
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Company
Overview
27 years
Experience in the Industry
Demonstrates a long-standing commitment to innovation and client success.
100k+ installations
Installed Systems Worldwide
Highlights global reach and widespread adoption of its solutions.
$2.5B
Annual Revenue
Reflects significant financial success and market impact.
- Provides cutting-edge software tools and professional services for network design and optimization.
- Recognized for versatility across industries, from telecommunication to utility networks.
- Dedicated to continuous innovation and enhancement of customer value.
- “Manufacturer’s Mindset™” — thinking like clients across every stage of project lifecycle
- “One Firm” philosophy — personal connection, hands‑on support, consistency at scale
- Built to Serve — flexible, agile business model independent of any single technology or delivery method
- Cultivating leaders — “leaders defining tomorrow” through unwavering shared values and culture
- Deep domain expertise in clean + regulated manufacturing across food, beverage, life sciences, advanced technology, industrial markets
2030 Target
Net Zero Emissions
Aiming to achieve net zero carbon emissions by 2030 across operations and supply chain.
25% Reduction
GHG Emissions Cut
BW Packaging plans to reduce Scope 1 & Scope 2 GHG emissions by 25% by 2030, using a 2021 baseline.
2024 Plan
Carbon Reduction
Carbon Reduction Plan 2024 follows RIBA Plan of Work, monitoring A1–A5 embodied carbon via QFlow.
- Sustainable procurement prioritizing local materials & certified suppliers
- Whole‑life carbon assessments embedded in project development stages
- LED lighting retrofits, renewable power procurement, HVAC optimization, destratification fan installation driving footprint reductions
- No official DEI strategy or gender‑based outcomes available on public website or LinkedIn.
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