Validation Engineering Roles

BW Design Group; Philadelphia (Philadelphia County); On-site; USD 80,000 - 120,000; Full time

Job summary

BW Design Group in Philadelphia is looking for Validation Engineers to enhance project delivery in the Life Sciences industry. You will lead client relationships and support compliance activities within pharmaceutical settings. Responsibilities include preparing validation documents, managing project lifecycles, and collaborating with clients. The ideal candidate will have a relevant engineering degree and experience in validation and project management. Strong communication skills and proficiency in tools like Microsoft Office are essential.

Qualifications

• Minimum 2-7 years project experience for Validation Engineer II in pharmaceutical environments.
• Minimum 7+ years for Sr. Validation Engineer in design and validation in drug systems.
• Minimum 10+ years for Sr. Project Manager with packaging and automation applications.

Responsibilities

• Assist with capital project CQV delivery and technical solutions for clients.
• Lead client relationships and project execution from concept to startup.
• Prepare and manage validation and compliance documents for pharmaceutical equipment.

Skills

Validation of automation systems

Project management

Communication skills

Technical writing

Education

Bachelor's degree in Engineering

Tools

Microsoft Office

Microsoft Project

AutoCAD

Job description

Who You'll Work With

Join one of our 45 offices in the US as part of a committed team of over 1500 professionals, working directly with clients on projects that shape the world around us. As a professional with BW Design Group, you'll be welcomed into a rapidly growing business and empowered to make an immediate impact. You'll work alongside seasoned leaders, technical specialists, and subject matter experts within our Regulatory Compliance Practice to deliver the highest quality solutions with consistency and accuracy.

What You'll Do

You'll support both capital project CQV delivery and individual technical contribution solutions for our clients within the Life Sciences industry. You'll help clients implement critical changes to improve their performance and realize their most important goals through:

Validation & Compliance Activities

• Assist basic and conceptual design phases of capital projects by working with clients and vendors on embedding compliance, testability and lifecycle thinking into early design
• Establish User Requirement Specifications for critical equipment and systems.
• Assess risk across various aspects of systems’ functions and focus efforts on critical quality aspects. Develop and execute validation and FDA compliance related documents/protocols for pharmaceutical equipment and processes – employing industry’s most progressive Digital Validation Tools
• Prepare, execute, and manage commissioning and qualification documents for utility, facility, and process equipment
• Perform FAT, SAT, IQ, and OQ documentation development and execution on Automated Systems
• Conduct investigations and troubleshoot validation-related issues
• Prepare comprehensive written validation reports.

Project Management & Leadership

• Lead all aspects of client relationship development and project execution
• Develop project plans, strategies, and manage project resources, budgets, and schedules
• Oversee complete project lifecycle from concept through design, implementation, installation, commissioning, and startup
• Manage multiple project responsibilities simultaneously with excellent organizational skills
• Focus on project success related to scope, schedule, budget, and client satisfaction

What You'll Bring

Experience Requirements (Based on Role Level):

• Validation Engineer II: Minimum 2-7 years project experience with validation of automation, packaging, drug substance (i.e., pooling, centrifugation, TFF) and/or drug product (i.e., filling, inspection) systems/equipment, utilities, and/or facilities in pharmaceutical or medical device environments
• Sr. Validation Engineer: Minimum 7+ years demonstrated experience with design, commissioning, validation of automation, packaging drug substance (i.e., pooling, centrifugation, TFF) and/or drug product (i.e., filling, inspection) systems/equipment, utilities, and/or facilities in pharmaceutical or medical device environments validation
• Sr. Project Manager: Minimum 10+ years project engineering, design engineering, or project management experience with packaging, processing, automation, or Life Science applications.
• CSV Engineer: A minimum of four years of computer system validation experience in the pharmaceutical, biotech, medical device or other FDA regulated industries, Competency with FDA Data Integrity requirements and exposure to data integrity risk and gap assessments Experience in generating software development life cycle documentation such as FRSs, SDSs, HDSs and configuration specifications Hands-on experience with Emerson DeltaV, Syncade, Allen Bradley PLC, Wonderware, OSI PI, or Rockwell software platform An understanding of laboratory systems and CSV for process control systems for clean utilities and bioprocess manufacturing equipment

Technical Skills & Qualifications

• Bachelor's degree in Engineering (Bioengineering, Biomedical, Chemical, Electrical, Mechanical, or equivalent technical degree)
• Validation experience in automation, packaging, general drug substance and/or drug product systems/equipment, computer systems, utilities, and/or facilities
• Strong technical writing and oral communication skills
• Proficiency with project documentation and computer skills (Microsoft Office, Microsoft Project, AutoCAD)
• Experience with entire project lifecycle from concept development through startup (preferred)

Professional Attributes

Excellent leadership and organizational skills with ability to manage multiple responsibilities

• Outstanding communication and interpersonal skills to interact with all levels of management, clients, and vendors
• Flexibility with tasks and strong analytical capabilities
• Willing and able to travel as necessary for project requirements including installation, startup activities, client meetings, and industry events.

Must be legally authorized to work in the United states without sponsorship