Sr. Validation Project Manager (Life Sciences)

BW Design Group; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Professional development resources

Flexible work environment

Job summary

A leading engineering consultancy in Irvine is seeking a Sr. Validation Project Manager with over 7 years of experience in validation and project management within the life sciences sector. This role involves interfacing with clients, leading teams, and developing project proposals while ensuring compliance with FDA regulations. Ideal candidates will possess strong leadership and communication skills and have a background in engineering. The position offers a competitive salary of $120k–$160k.

Qualifications

• Minimum of 7 years’ experience in validation/quality service and project management in life sciences.
• Strong understanding of regulatory compliance and project management tools.
• Diverse experience in commissioning and qualification of clean utilities.

Responsibilities

• Interface with clients and lead validation teams.
• Develop project scope statements and proposals.
• Manage multiple projects while ensuring quality and compliance.

Skills

Project management

Communication skills

Leadership skills

Technical writing

Financial systems experience

Education

BS Degree in Engineering or related technical degree

Job description

Sr. Validation Project Manager

Who You’ll Work With

you will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world‑class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

When you join Design Group as a Sr. Project Manager, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject‑matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

What You’ll Do

• Sr. Project Manager will interface with clients, lead teams of validation professionals, and provide subject‑matter expertise in the validation of a variety of utility, facility and process equipment.
• The Sr. Project Manager will help lead business development efforts in the region as it relates to engaging with new clients in the life sciences sector, and expanding our engagements with existing clients.
• The Sr. Project Manager will be responsible for developing project scope statements, estimates and proposals.
• Will work on multiple projects simultaneously.
• Make an impact day‑to‑day with your skills and expertise, strengthening that relationship with our clients and team.

What You’ll Bring

• Minimum of 7 years’ experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA‑regulated projects.
• This position requires 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.
• Strong understanding of EPCMV, Quality by Design and risk‑and‑science‑based approaches for compliance are desired.
• Experience with system and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis desired.
• Experience with financial systems, project, and client administration.
• Requires strong leadership, verbal communication, technical writing, project management tools and word processing skills.
• Diverse experience in leading 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.
• Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.
• Project Management experience in managing scope, cost, schedule, quality, and risk is required.
• Experience in mentorship and multi‑discipline collaboration.
• 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.
• BS Degree in Engineering or related technical degree.

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Sr. Project Manager, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world‑class engineer and a highly effective leader.

Feel like you’re on the path to becoming a Sr. Project Manager but you’re not quite there yet? We’d love to connect with you to see if we can take you from where you are today and grow you into a Design Group Engineering Consultant.

The approximate pay range for this position is $120k–$160k. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and abilities as well as geographic location of the position.