Senior Validation Project Manager

Caiready; Denver (CO); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

4% retirement contribution

24 days PTO

5 sick days per year

Health insurance

Professional education support

70% long term disability paid by the公司

Job summary

The CAI project management team seeks a seasoned Project Manager with a strong CQV background to lead multi-million dollar life sciences programs in the Denver area. You will direct scope, schedule and budget, and mentor 6-8 engineers and consultants across defined work streams.

Ideal candidates bring 8-12 years commissioning and qualification experience, hands-on field execution, and excellent leadership under pressure. PMP is a plus; regional travel may be required to support clients globally.

Qualifications

• BS in a science or engineering field or equivalent experience.
• 8-12 years’ Experience commissioning and qualifying bio-pharma systems equipment and systems.
• Experience with risk assessments, qualification protocols, commissioning plans/test scripts and summary reports is desired.
• Three (3) or more years serving as a program or project manager for life science projects with budgets of $1MM+.

Responsibilities

• Lead budget reviews and schedule management for multi-million dollar programs.
• Run daily team huddles and ensure on-time delivery of defined scopes.
• Review summary reports, write protocols, and support field execution.
• Manage teams of 6-8 engineers and consultants across defined work streams.

Skills

CQV management

Team leadership

Budget management

English proficiency

Education

BS in science/engineering

Tools

PM software tools

Job description

Our project managers are technical leads first, with a strong background in CQV strategy, development, and field execution.We look for culture fit above all – our people are our most important asset, and great people make great teams!Our ideal project manager will have experience managing projects of $1m or more, and have managed teams of at least 6-8 engineers and consultants on defined scopes of work.

A successful CAI PM will need to show direct responsibility for scope/schedule/budget for project experience.We love experienced generalists, but if you’re a CQV SME in facilities, clean utilities, upstream and downstream biotech equipment, single use disposable, or aseptic fill finish manufacturing, we’d like to talk to you!A PMP is great, but you’ll need the experience if you want to run with a CAI team.On any given day, you might be leading a budget review meeting, leading a daily huddle with your team, reviewing a summary report, writing a protocol, or supporting your team executing in the field.CAI PMs are active, multifaceted roles - desktop PMs need not apply!The CAI project manager typically reports to either a client manager or an area manager.

Requirements include:

Requirements Include:

BS in a science or engineering field or equivalent experience

8-12 years’ Experience commissioning and qualifying bio-pharma systems equipment and systems

Experience with risk assessments, qualification protocols, commissioning plans/test scripts and summary reports is desired Experience with CIP/SIP is desired

Excellent skill in leading teams to perform complex tasks under pressure

Excellent problem-solving skills

Proficient and experienced with various Project Management software tools

Customer-service focused

Three (3) or more years serving as a program or project manager for life science projects with budgets of $1MM+. Demonstrated success in leading your team to achieve defined goals. Similar experience in industries other than life sciences will be considered.

Other Requirements:

Excellent oral and written communication skills in English

Able to travel domestically and internationally as required

Able to work (paid) overtime

Able to work in the US without sponsorship now or any time in the future.

About CAI

CAI is a professional services company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.

Are You Ready?

Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.

As employees of CAI, we are committed to living our Foundational Principles, both professionally and personally:

We act with integrity.

We serve each other.

We serve society.

We work for our future.

With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.

Our full-time positions offer competitive compensation and benefits which include: 4% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.