Who We Are
Commissioning Agents, Inc., is a rapidly expanding 300-person professional services organization working across the globe to create change in the industries in which we work. As a member of our team you will work at the leading edge of the pharmaceutical, biotechnology, medical device, nutritional, power generation, and building commissioning industries to advance knowledge and provide industry best-practices to our clients. While our headquarters is located in the United States, we have offices in Puerto Rico, the United Kingdom, Ireland, Singapore and China. Please take this opportunity to learn about Commissioning Agents, where we believe that our employees are our most important asset and are dedicated to creating and maintaining a great place to work.
- Responsible for managing and executing the commissioning, qualification and validation of manufacturing equipment, lab equipment, infrastructure (i.e. hardware/equipment, infrastructure software components) and software to assure quality and stability prior to deployment in our production environments.
- Ensures that the applicable regulations, guidelines and internal procedures related to validation of manufacturing equipment, lab equipment, computer systems and associated infrastructure are followed and applied during all stages of project activities.
- Analyzes the validation impact of changes and helps in formulating the validation strategy for changes to existing or new equipment, computer systems and infrastructure.
- Creates qualification and validation deliverables, such as system impact assessment, validation protocols, data migration plan and summary, commissioning plans and scripts, OQ protocol and scripts, test summaries, validation project plan, etc. for new functionality, enhancements, maintenance releases, periodic reviews.
- Works with Operations, Quality Assurance, Business Quality & Compliance teams, and Project Managers to evaluate and set testing milestone criteria to ensure released products are on schedule and of high quality and meet quality compliance requirements.
- Identifies and coordinates activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, executing qualification protocol or validation project plan, managing change control (change requests).
- Supports risk assessment and control activities.
- Supports system lifecycle processes such as change control and document management.
- Occasionally provides training related to manufacturing, infrastructure, computerized systems and compliance.
- Assists in resolving and documenting technical and project-related issues.
Who You Are
- Five+ years of qualification and/or validation experience in a Regulated/ Validated environment.
- Formal training and proficiency in software development methodologies and computer systems validation in regulated industries (biotech/pharma).
- One to 3 years experience in biotech or pharma, with exposure to corporate, enterprise systems and platforms.
- Expertise in interpretation of the applicable regulations that impact computer systems (e.g., 21 CFR Part 11) used in GxP/cGMP environment and related FDA guidelines, regulations, as well as ICH GCP guidelines.
- Exposure to one or more of the following areas of Commissioning
o Requirements development
o Planning and schedule development
o Design and submittal reviews
o Pre-delivery inspections
o Factory and site acceptance (FAT/SAT) support
o Equipment receipt and installation inspections
o Construction quality oversight/ in-process inspections
o Execution coordination/ management
o System start-up/ shakedown / troubleshooting
o Functional and performance testing
o DCS, BAS/ BMS, and PLC Installation Checkout
- Exposure to one or more of the following areas of validation (Process/Cleaning/Sterilization/Computer System/Automation)
- Effective oral and written communication skills.
- Proficient in validation process methodologies, risk management, etc.
- Good understanding of the standard project and/or SDLC methodologies.
- Ability to assemble, analyze and evaluate data and to be able to make appropriate and well-reasoned recommendations and decisions to the Business stakeholders and team members.
- Must be able to manage multiple tasks and be able to work independently.
- Must be able to accept unexpected assignments as needed.
- Customer focus and being a team player are a must.
- Bachelor’s degree or equivalent work experience in a Life Science, Engineering, Computer Science or another related discipline preferred.
If you are looking for an organization where you can truly make a difference in people’s lives, look no further. Commissioning Agents is an Equal Opportunity Employer.
Qualified candidates must be legally authorized to be employed in the United States. CAI does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
We welcome your interest in our organization and are pleased to accept applications if your background and interests match the work and goals of our company. However, due to the volume of inquiries we receive, we will only respond directly to your application if it matches a current opening and if your qualifications match our needs.
Indeed - 7 months ago