CQV / Validation Engineer

Salas O'Brien; Chapel Hill (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking CQV Engineers to join their dynamic team. This role involves performing critical commissioning, qualification, and validation activities within the pharmaceutical and biotechnology sectors. You will collaborate with various teams to ensure compliance with cGMP guidelines and contribute to the development of validation objectives. With a focus on innovation and excellence, this forward-thinking firm offers a supportive environment where your expertise will directly impact the success of vital projects. If you are passionate about engineering and eager to make a difference, this opportunity is perfect for you.

Qualifications

• 5+ years of experience in CQV within a cGMP environment.
• Strong understanding of commissioning activities and validation processes.

Responsibilities

• Perform CQV activities and control CQV plans.
• Generate C&Q procedures and maintain safety regulations.

Skills

Commissioning

Qualification

Validation

Technical Documentation

Communication Skills

Life Sciences Manufacturing Processes

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Job description

Founded in 1975, Salas O’Brien is an employee-owned engineering and professional services firm focused on achieving positive impact for our clients, our team, and the world. We know that tomorrow’s requirements are today’s opportunities, and we are here to design lasting solutions for pressing challenges.

We work across a variety of industries providing integrated engineering and consulting services. Our specialized experience includes design for data centers, healthcare, science and technology, high-rise buildings, clean energy, education, and other building types as well as structural and building sciences, infrastructure asset management, advanced robotics, and more.

Hughes Consulting, A Salas O’Brien Co., is currently accepting applications for CQV Engineers with relevant experience in either facilities, equipment or utilities within a pharmaceutical or biotechnology manufacturing environment to support future projects.

• Perform Commissioning, Qualification, Validation team activities.
• Control CQV plan by reviewing documentation, protocols, procedures, and execution strategies, coordinating with vendors and team members.
• Generate C&Q Procedures.
• Participate in the development of CQV Planning, ETOP and Documentation Reviews, Protocol Generation and Protocol Execution.
• Help develop Validation objectives by reviewing project proposals and plans, conferring with management.
• Prepare validation reports by collecting, analyzing, and summarizing information during execution.
• Work with startup teams during the commissioning and validation phases of a project, ensuring clear communication and hand-off of information.
• Maintain a safe and clean working environment by enforcing procedures, rules, and regulations.

You will have:

• Bachelor’s or Master's degree in Engineering or related field (Chemical, Mechanical or equivalent preferred).
• Minimum 5 years of relevant work experience in Commissioning, Qualification and Validation of Equipment, Utilities or Facilities within a cGMP environment.
• Strong understanding of commissioning activities.
• Proficiency in life sciences manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, critical utilities.
• Knowledge of industry regulated guidelines for the validation of cGMP facilities.
• Excellent verbal and written communication skills.
• Technical Documentation Skills.

Desired Skills:

• Ability and willingness to travel.

Equal Opportunity Employment Statement

Salas O’Brien provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state/provincial, or local laws. Salas O’Brien will accommodate the disability-related needs of applicants as required by law.

Seniority level

Associate

Employment type

Full-time

Job function

Engineering, Manufacturing, and Other

Industries

Pharmaceutical Manufacturing, Engineering Services, and Manufacturing