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Description:

This company is the world’s largest nuclear medicine company with more than a century of industry experience. They develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. This company delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. They are looking to add a Validation Engineer to their team locally in Noblesville, Indiana.

This position will report to the Director of Operations and work cross functionally with the quality, manufacturing and regulatory team. This validation engineer will be conducting assessments, reviewing standard operating procedures (SOPs), and generating validation documentation, such as protocols, and reports while Hands-on validation work may involve programming and operating equipment like the Kaye Validator 2000 for temperature mapping, as well as executing (IQ), (OQ), (PV), (PQ) activities.

Essential Functions

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOPs.

• Ensure the maintenance of their department, premises and equipment.

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Provide validation manager/supervisor backup and site support.

• Independently plan, perform and document validation activities (IQ, OQ, PV, PQ) for new and existing equipment, facilities and utilities in a pharmaceutical manufacturing, manufacturing support and QC environments.

• Create validation schedules, coordinate execution efforts with contractors, production operators, production engineers, lab personnel and quality assurance staff members.

• Track and communicate progress of work against milestones.

• Write validation plans, protocols, traceability matrices, FMEAs and final report summaries.

Must Haves:

1. Bachelors Degree in Chemical, Biological, or related.

2. 5+ years experience as a validation engineer within Pharma or radiopharma

3. Knowledge of global cGMPs and EU standards for Pharmaceutical Manufacturing

4. Proven experience in pharmaceutical manufacturing preferably Sterile Injectables

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.