Equipment Validation Engineer

San Diego, CA posted on June 4

Formed in 2002 out of a need for high-caliber consultants within the life sciences industry. Sequence, Inc. is well-known in regulated industries as a validation and engineering services provider, specializing in quality and compliance services for software, IT infrastructure, laboratory instruments, analytical methods, equipment, automation, processes, cleaning and utilities, as well as process optimization, laboratory software support, remediation, regulatory compliance services, system/facility startup and much more. All of our work is done in-house with oversight from a management team that cut its teeth in regulatory compliance.

We have specialized experience integrating and validating many automation and software solutions widely used in regulated industries, allowing us to offer related support and administration services for comprehensive compliance solutions.

We are currently seeking multiple Equipment Validation Engineers (Consultant and Senior Consultant level) for our Equipment and Utilities Validation Division. 

 

Essential Functions and Responsibilities:

  • Create and execute commissioning and qualification protocols/test plans for facilities, utilities and equipment using a risk based approach
  • Create equipment and process specification documentation 
  • Conduct field inspections including piping and equipment walk downs, operational startup and troubleshooting
  • Track and report on progress to project deliverables, schedules and budgets
  • Develop risk assessment, system impact assessments and validation plans
  • Investigate deviations and write investigation reports
  • Review, analyze and interpret system performance data for completed qualification and prepare final package to summarize data

 

Minimum Requirements:

  • Ability to communicate effectively at all levels in verbal and written form
  • Capability to read and redline equipment P&ID and facility layout drawings
  • Knowledge of validation lifecycle approach (URS, FRS, FAT/SAT, Commissioning Protocols, etc.)
  • Working knowledge of Quality by Design (QbD) principles and approach
  • Bachelor’s degree in life sciences, engineering or other related technical field (or equivalent experience)
  • 1+ years in validation, quality systems, operations or engineering in pharmaceutical or other regulated industry

 

Our consultants must be knowledgeable and willing to go the extra mile in service of a client, your success is our success. Here are some of the Benefits we offer:

  • Competitive Pay
  • Medical, dental, and vision Insurance
  • 401k plan with employer contributions
  • Generous PTO/ Time off
  • Bonus Plan
  • Reimbursable Expenses (Phone, Internet, and Mileage to Client Site)

We value our employees, and beyond the great pay and benefits we offer, we care most about offering opportunity. We are a rapidly growing consulting firm, and would love to discuss the prospect of you joining our team. Sequence Inc. is proud to be an Equal Opportunity Employer, M/V/D/F. You will be considered for this position based upon you experience, without regard to race, color, religion, sex, national origin, age, sexual orientation, ancestry; marital, disabled or veteran status.  We are unable to sponsor at this time.


Wage

DOE

Experience

Any

Type

Full-time