Engineering Client Development Lead, Validation and Regulatory Compliance

Overview

Lead validation and regulatory compliance projects for life‑science clients while expanding market presence.

Key Responsibilities

• design innovation
• client requirements
• project planning
• budget review
• material research
• technical coordination

Tasks

-Innovate and improve design and service delivery method and processes -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 -Build and sustain long term client and internal relationships -Participate actively in relevant industry organization events and conferences -Assist in the education and development of the team and act as resource for questions. -Travel as required for client development and project execution -Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team -Understand and develop design intent based on client objectives and provide excellent client service -Create integrated solutions and communicate key concepts to the client -Assign and review work of project team. -Assess the requirements of a project, break a project into tasks, and work with teams to determine scope of work, budget and staffing -Prepare or review budgets based on experience and scope of project. -Research material options to deliver an optimal solution for the client when required by project scope -Develop the base plan and coordinate technical requirements with engineering disciplines -Check progress of work and alert project leads to change of scope or additional services.

Requirements

• gamp
• 21 cfr
• cgmp
• bs engineering
• 15+ years
• project management

What You Bring

-Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity. -Excellent time management skills and ability to multi-task on simultaneous projects -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. -Displayed leadership in a consulting and service environment. -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. -Display enthusiasm and excitement for client projects that lifts project teams to high levels of job satisfaction -BS Degree in Engineering or related technical degree -15+ years of Life Science operational & engineering experience in the pharmaceutical, biotech or medical device sectors - Client side & Consulting experience highly preferred -Project Management experience in managing scope, cost, schedule, quality and risk is required. -10+ years’ experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects -Experience with creating proposals and business development. -Strong leadership, verbal communication, technical writing, project management tools and word processing skills. -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. -Experience building, managing, and leading teams -Experience with financial systems, project, and client administration -Communicate and interact directly with clients in a collaborative and professional manner -Demonstrated client development experience and excellent presentation skills -Coordinate all aspects of project document completion within company and externally with clients and other design professionals. Proficient written and oral communications skills.

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About Bw Design Group

-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.

Sector Specialisms

Security Clearance

-drug screening -reference checks -employment verifications -background screening -skills assessments