Commissioning Agents Inc

Validation Engineer

Commissioning Agents Inc$75K — $90K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a science or engineering field or equivalent experience
  • 2-4 years' experience in commissioning and qualification in a regulated industry
  • Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus
  • Experience with facilities and equipment startup and troubleshooting
  • Knowledge of utilities (WFI, RO, HVAC) and pharmaceutical manufacturing processes

Responsibilities

  • Develop documentation for CQV activities
  • Write and execute field verification protocols
  • Create summary reports at client sites
  • Plan and coordinate work for projects
  • Lead small teams in document development and execution

Benefits

  • Comprehensive Health Insurance coverage
  • 24 days of Paid Time Off
  • Company paid Life Insurance
  • Company paid Long Term Disability
Full Job Description
Key Responsibilities

1. Technical Responsibilities

- Develop documentation for CQV activities

- Write and execute protocols (field verification)

- Develop summary reports at client sites

2. Areas of Focus

- Pharmaceutical facilities

- Utilities

- Equipment

3. Project & Team Management

- Plan and coordinate work

- Direct small teams in document development and/or execution

Qualifications and Experience

- Bachelor's degree in a science or engineering field (or equivalent experience)

- 2-4 years' experience in commissioning and qualification in a regulated industry

- Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus

- Preferred experience in:

- Facilities and equipment startup

- Walk-downs and troubleshooting

- Utilities (WFI, RO, HVAC)

- Upstream/downstream processing

- Purification, recovery

- Building automation

- Pharmaceutical manufacturing processes

Critical Competencies

Influence Strategy

- Pursues initiatives aligned with organizational strategy

- Identifies strategic, innovative solutions

- Anticipates emerging customer/market needs

Satisfy the Customer

- Understands and anticipates customer needs

- Delivers high-quality solutions and service

- Proactively maintains satisfaction and loyalty

Plan for Success

- Aligns business strategies with actionable plans

- Anticipates risks and builds contingency plans

- Secures resources for goal achievement

Pursue Execution

- Prioritizes time and resources effectively

- Holds self and others accountable

- Acts to overcome obstacles and improve quality

Tailor Communication

- Communicates clearly and professionally

- Adjusts style to fit the audience

- Explains technical concepts effectively

Build Partnerships

- Builds networks across functions

- Encourages collaboration and breaks down silos

- Involves stakeholders in decisions

Influence Others

- Builds support with sound rationale

- Gains buy-in from decision makers

- Encourages innovative thinking

Develop Self and Others

- Enhances interpersonal relationships

- Models integrity and company values

- Seeks out growth and breakthrough opportunities

#LI-MV1

$75,000 - $90,000 a year

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

CAI Benefits:
• Comprehensive Health Insurance coverage
• 24 days of Paid Time Off
• 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 and identifying potential inconsistencies or verification signals in application materials based on available information. 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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