Sr. Validation Engineer

4 weeks ago

Noblesville, United States Actalent Full time

Job Title: Validation EngineerJob Description

We are seeking a Validation Engineer to join our team in Noblesville, Indiana. As the world's largest nuclear medicine company with over a century of industry experience, we develop, manufacture, and distribute world-class radiopharmaceutical products. Our solutions help over 14 million patients annually by providing SPECT, PET, and therapeutic radiopharmaceutical solutions for life-threatening diseases. The Validation Engineer will report to the Director of Operations and work cross-functionally with the quality, manufacturing, and regulatory teams. Responsibilities include conducting assessments, reviewing standard operating procedures (SOPs), and generating validation documentation such as protocols and reports. Hands-on validation work may involve programming and operating equipment like the Validator 2000 for temperature mapping, as well as executing IQ, OQ, PV, and PQ activities.

Hard Skills

+ Bachelor's Degree in Chemical, Biological, or related field

+ 5+ years of experience as a validation engineer within radiopharma

+ Knowledge of global cGMPs and EU standards for Pharmaceutical Manufacturing

+ Proven experience in pharmaceutical manufacturing, preferably Sterile Injectables

Soft Skills

+ Ability to independently plan, perform, and document validation activities

+ Strong communication skills to track and communicate progress of work against milestones

+ Ability to create validation schedules and coordinate execution efforts with various teams

Job Type

This is a Contract-to-Hire position with a duration of 6 Month(s).

Work Site

This is a fully on-site position in Noblesville, Indiana.

Work Environment

Onsite role: 8am-5pm, Monday-Friday, with minimal potential for remote work for documentation. The role involves a mix of time on the manufacturing floor and working in the office for documentation review and meetings.

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.

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