CASY-MSCCN Jobs

* SENIOR VALIDATION ENGINEEER*

Description:

The Senior Validation Engineer will mentor and support in the diagnoses and resolution of software, instrument, and process problems to maintain system readiness of both packaging equipment and data historian network. You will ensure site compliance and all vital activities are performed on time to keep all validated systems in a validated state. In this role, you will also create and implement the site’s validation strategy.

1. Mentoring and supporting the diagnosis and resolution of software, instrument, and process issues to maintain system readiness.

2. Ensuring site compliance and ensuring that all vital activities are performed on time to maintain validated systems in a validated state.

3. Creating and implementing the site's validation strategy.

Key Duties and Responsibilities:

• Assess and define assigned validation projects, acting as a liaison between engineering and quality assurance throughout the validation lifecycle of packaging equipment and data historian network.

• Develop validation strategies based on User Requirement Specifications (URS) and Process Failure Mode and Effects Analysis (pFMEA).

• Write, review, and implement project validation protocols for standard and customized systems.

• Raise and resolve discrepancies, and closeout test documentation.

• Prepare validation summary reports for completed protocols.

• Conduct deviation investigations, such as validation failures, complaints, and hold investigations, to identify and implement appropriate corrective actions.

• Apply structured problem-solving tools, and collaborate with Operations to resolve technical issues and rationalize the impact on the validated state.

• Author operational guidance documents (Standard Operating Procedures, Work Instructions, Job Aids, and Forms) and conduct relevant training sessions.

• Partner with the quality assurance team to participate in internal and external audits, defending equipment validation packages, including calibration and maintenance.

Top Skills' Details

• Bachelors degree in Engineering or another scientific subject area from an accredited College

• Minimum of 3 years of validation experience in a regulated industry or equivalent validation experience that included the development and execution of FAT, SAT, and IQ/OQ protocols.

• Demonstrated understanding of cGMP, GDP, and regulatory requirements for automated systems, CPPs, and CQAs, pFMEAs

Additional Skills & Qualifications:

Nice to have:

• Experience working with Trackwise, Maximo, and other electronic document management systems preferred.

• Experience with DeltaV or similar automation system preferred.

• Experience with computer systems validation, cleaning validation, and environmental monitoring preferred.

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.