Validation Engineer

Description:

This engineering position supports manufacturing activities associated with manufacturing process equipment. The engineer works in partnership with the maintenance Project Management Engineering Technical Lead and manufacturing to develop improve and oversee the operation and reliability of equipment. The Engineer role will provide direct engineering technical support as follows:

• Identify support and/or lead implementation of engineering based improvements or upgrades to the equipment systems. This may include development of reason for improvement and identification of design requirements and then translation of requirements into process equipment/system design specification and supporting the construction startup and validation of equipment.

• Support Lean Transformation and Excellence in Operations process improvement by leading supporting and documenting improvement opportunities to reduce cost improve safety/quality or improve speed.

• Be individually accountable for the verification deliverables on key capital projects.

• Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order.

• Provide oversight for verification deliverables developed by outsourced/contract verification staff.

• Develop commissioning and function test plan for any equipment modifications and acquisition.

• Ensure safety during commissioning validation maintenance and manufacturing activities.

• Support Manufacturing and QA with Performance Qualification PQ activities if applicable.

• Act as a liaison between Engineering and Manufacturing during project planning execution and closeout.

• Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification.

Preferred Qualifications / Skills / Experience

• Bachelors degree in chemical or other Engineering fields

• 6 years' of relevant work experience with 5 years' experience in Biopharmaceutical operations/manufacturing environment

• Experience working in a regulated environment e.g. cGMP OSHA EPA etc. and familiarity with GMP quality systems/processes such as change control nonconformances corrective and preventative actions and qualifications/validation.

• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors chromatography filtration as well as other equipment needed to support these processes such as autoclaves clean in place CIP systems washers clean steam etc.

• Ability to analyze problems develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses e.g. Root Cause Analysis

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.