Computer Software Assurance Associate Director

Flexible - Depending Upon Candidate  /  Commissioning & Qualification  /  Full Time

About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to more than 700 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.
Meeting a Higher Standard
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 owners 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: 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.
CAI CSA Discipline Leads will be exposed to cutting edge technologies and project management practices in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
Position Description:  
As a Discipline Lead for the CQV/Automation Business Area at CAI, you are a subject matter expert who: 
1.     Is engaged in industry forums, speaking, writing articles, participating in society committees, supporting standards or guidance document creation within such groups, and has a network of industry contacts who would recognize you as being an expert in regulated automation engineering, CSA, CSV, Data Integrity etc.
2.     Knowledgeable in current and planned regulations and good practices associated with CSA, GAMP, Data Integrity and the software development and verification lifecycle.
3.     Can provide consulting to clients in several areas to include automation, CSA, CSV, IT, Data Integrity, Artificial Intelligence, Machine Learning.  Broad System experience over multiple automation systems.
4.     Engages in strategic project work designed to be a door-opener for larger teams once the initial expert engagement is over, or as part of a larger project to deliver special expertise.
Additionally, you may be responsible for the management of automation projects acting as a client representative and/or a CAI PM leading a team under a scope of work. You may be assigned to manage internal programs with cross-functional teams comprised of client employees and/or contractors.  Alternatively, you may be assigned to lead programs performed by external suppliers in which you will be responsible to manage supplier performance per established contracts and quality agreements.  You will interact and engage with stakeholders across the project spectrum and be responsible for driving the project to success.
Position Requirements:
BS in a relevant science or engineering field, or equivalent
Excellent skill in leading teams to perform complex tasks under pressure
Excellent problem-solving skills
Proficient and experienced with various automation software products: PLC, SCADA, DCS, MES, IT, ERP, LIMS, SAP, PI, CMMS, Apps, etc.
Customer-service focused
Eight (8) or more years serving as an Automation Engineer or similar for life science projects.  Demonstrated success in leading your team to achieve defined goals.  Similar experience in industries other than life sciences will be considered.
Life Sciences project delivery experience in EPC, integrator, or automation vendor companies
Demonstrated skill in:
Automation requirements definition and specification
Automation design and implementation
Automation troubleshooting
Automation test planning, generation, and execution
Business Development
Other Requirements:
Excellent oral and written English is required
Able to travel domestically and internationally if required 
Able to work (paid) overtime 
Able to work in the US without sponsorship now or any time or in the future
Must have been vaccinated or willing to be vaccinated for COVID-19 prior to starting employment



(Varies by Country, Below is a General Overview)

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
  • Other Benefits Depending on Country