Commissioning Agents Inc

Senior Validation Project Manager

Commissioning Agents Inc • $102K — $111K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in science or engineering or equivalent experience
  • 8-12 years' experience in commissioning and qualifying bio-pharma systems
  • Experience with risk assessments and qualification protocols
  • Excellent team leadership skills under pressure
  • Proficient in project management software
  • Three or more years as a project manager for life sciences projects with budgets of $1MM+
  • Strong communication skills in English

Responsibilities

  • Lead project teams to execute commissioning and qualification tasks
  • Manage scope, schedule, and budget for projects over $1M
  • Conduct budget review meetings and team huddles
  • Write protocols and summary reports
  • Support team execution of projects in the field

Benefits

  • Up to 15% retirement contribution
  • 24 days paid time off and 5 sick days annually
  • Comprehensive health insurance at low cost to employee
  • Financial support for professional education
  • Company paid life insurance and long-term disability
Full Job Description
Position 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.

Benefits

Our full-time positions offer competitive compensation and benefits which include: up to 15% 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.

#LI-MV1

$102,100 - $111,700 a year

Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.

CAI Benefits:
• Comprehensive Health Insurance coverage
• 24 days of Paid Time Off
• ESOP/401K - 15% Company Contribution (US Only)
• Company paid Life Insurance
• Company paid Long Term Disability

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

About Commissioning Agents Inc

Commissioning Agents, Inc. (CAI) is a pharmaceutical consulting firm that provides commissioning, qualification, validation, and quality services to pharmaceutical, biotechnology, and medical device companies. The company was founded in 1996 and is headquartered in Shrewsbury, New Jersey. CAI has offices in the United States, Europe, and Asia.
Learn more about Commissioning Agents Inc
Size
500 employees
Industry
Net Income
$10 million
Founded
1996
5 Year Trend
+10%
Revenue
$100 million

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