Validation Engineer

Azzur Group; Los Angeles (CA); On-site; USD 90,000 - 115,000; Full time

Job summary

An established industry player seeks a skilled CQV Engineer to ensure successful commissioning, qualification, and validation in the pharmaceutical and medical device sectors. This role offers the opportunity to work within a dynamic consulting team, where your expertise will directly impact life science companies. You'll develop and execute protocols, ensure compliance with regulatory standards, and provide mentorship to junior members. Join a company that values innovation, collaboration, and personal growth while making a difference in the healthcare landscape. If you are passionate about quality-driven solutions, this role is perfect for you.

Benefits

Health Care Plan (Medical, Dental & Vision)

Retirement Plan (401k)

Life Insurance (Basic, Voluntary & AD&D)

Paid Time Off (Vacation, Sick & Public Holidays)

Qualifications

• Strong technical expertise in CQV processes.
• Solid understanding of GMP regulations and industry standards.
• Excellent communication and interpersonal skills.

Responsibilities

• Develop and execute commissioning and qualification protocols.
• Ensure compliance with regulatory guidelines and industry standards.
• Communicate effectively with clients and project teams.

Skills

Commissioning

Qualification

Validation

Project Management

Regulatory Compliance

Analytical Skills

Problem-Solving

Education

BS in Engineering

BS in Science

Job description

5 days ago Be among the first 25 applicants

Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!

We are seeking a highly skilled CQV Engineer to join our consulting team. The CQV Engineer will play a crucial role in ensuring the successful commissioning, qualification, and validation of facilities, equipment, and processes in the pharmaceutical, biotechnology, and medical device industries. The ideal candidate will possess strong technical expertise, project management skills, and a thorough understanding of regulatory requirements.

Key Responsibilities:

• Commissioning, Qualification, and Validation
• Develop and execute commissioning and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Coordinate and oversee the installation, testing, and validation of equipment and systems.
• Ensure compliance with regulatory guidelines (FDA, EMA, etc.) and industry standards (GMP, GxP).
• Prepare and review validation documentation, including Validation Master Plans (VMP), User Requirement Specifications (URS), and risk assessments.
• Perform validation activities for processes, systems, and equipment, including writing and executing test plans and reports.
• Identify and resolve deviations and non-conformities, ensuring timely corrective actions.
• Communicate effectively with clients, project teams, and stakeholders to ensure project objectives are met.
• Provide technical guidance and mentorship to junior team members.
• Contribute to the development and implementation of best practices and standard operating procedures (SOPs) in CQV activities.
• Stay current with industry trends, technological advancements, and regulatory changes.

Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!

We are seeking a highly skilled CQV Engineer to join our consulting team. The CQV Engineer will play a crucial role in ensuring the successful commissioning, qualification, and validation of facilities, equipment, and processes in the pharmaceutical, biotechnology, and medical device industries. The ideal candidate will possess strong technical expertise, project management skills, and a thorough understanding of regulatory requirements.

Key Responsibilities:

• Commissioning, Qualification, and Validation
• Develop and execute commissioning and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Coordinate and oversee the installation, testing, and validation of equipment and systems.
• Ensure compliance with regulatory guidelines (FDA, EMA, etc.) and industry standards (GMP, GxP).
• Prepare and review validation documentation, including Validation Master Plans (VMP), User Requirement Specifications (URS), and risk assessments.
• Perform validation activities for processes, systems, and equipment, including writing and executing test plans and reports.
• Identify and resolve deviations and non-conformities, ensuring timely corrective actions.
• Communicate effectively with clients, project teams, and stakeholders to ensure project objectives are met.
• Provide technical guidance and mentorship to junior team members.
• Contribute to the development and implementation of best practices and standard operating procedures (SOPs) in CQV activities.
• Stay current with industry trends, technological advancements, and regulatory changes.

Requirements

• BSin Engineering, Science or equivalent technical degree.
• Solid understanding of GMP regulations and industry standards.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively in a dynamic team environment.
• Experience in commissioning, qualification, and validation within the pharmaceuticaland/or medical device industrycommensurate with the level of the project demand.
• Strong analytical and problem-solving skills with attention to detail.

Salary Range: 90k-115k

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Consulting

• Industries

  Pharmaceutical Manufacturing

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