Computer System Validation Engineer

Avid Bioservices; Tustin (CA); On-site; USD 82,000 - 104,400; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Job summary

A leading biopharmaceutical company in California seeks an Engineer for IT Systems Compliance. This role involves validating manufacturing equipment and laboratory instruments within a cGMP environment. You will review specifications, generate validation protocols, and engage collaboratively with various departments. The ideal candidate holds a scientific or engineering degree, has over three years of relevant experience, and thrives in a detail-oriented team atmosphere. Compensation is competitive with opportunities for growth.

Qualifications

• 3+ years experience in biopharmaceutical manufacturing.
• 1+ year in validation directly.
• Strong analytical skills.

Responsibilities

• Review and author User Requirement Specification documents.
• Generate and execute validation protocols.
• Coordinate validation activities with departments.
• Evaluate and analyze qualification data.
• Document deviations and ensure compliance.
• Develop validation policies and procedures.

Skills

Validation compliance expertise

Technical documentation

Cross-functional coordination

Detail-oriented

Strong communication skills

Education

BA/BS in science or engineering

Job description

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.

Your Role:

The Engineer, IT Systems Compliance is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that have been newly installed, upgraded, replaced and/or modified in the cGMP Manufacturing Facility as well as its related manufacturing support areas, which may include Facilities/ Engineering, Quality Assurance, Supply Chain, and Quality Control.

Responsibilities:

• Review and help author User Requirement Specification (URS) and/or Requirement Specification documents for manufacturing equipment/systems and processes
• Generate and execute Installation, Operational and Performance/Process qualification (IQ, OQ, PQ) protocols, engineering studies and final reports that comply with corporate and regulatory requirements.
• Coordinate and oversee validation protocol execution or validation activities with cross-functional departments.>
• Evaluate and analyze qualification data collected during projects, while verifying acceptability of the data and compliance with the approved protocol.
• Ensure any deviations to protocols and/or deviations to acceptance criteria are adequately addressed, documented and reviewed by Validation Committee.
• Provide input and assist on the development of validation policies and procedures.
• Effectively interact and provide validation guidance to other departments.
• Assist department manager in developing realistic time and resource requirements for validation activities in support of company expectation.
• Provide input and assist in change control assessment and Part 11 assessment for validated systems.
• Review Standard Operating Procedures (SOPs) and ensure the operational parameters described in the SOP for the equipment reflects validated conditions.
• Assist department manager on other types of projects/managerial responsibilities as needed

Minimum Qualifications:

• BA/BS in science (such as Biology, Microbiology, Biochemistry, Chemistry), Engineering (such as Electrical, Electronics, Computer Science) or other equivalent technology related field.
• Minimum of 3 years' work experience in biopharmaceutical/pharmaceutical manufacturing environment of which 1 year is directly involved in validations.

Position Type/Expected Hours of Work:

This role is a full-time position. Days and hours of work are Monday through Friday, 8am to 5pm PST, unless otherwise stated by Supervisor.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $82,000- $104,400 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.