Description:

this client 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.

The Manufacturing Technical Writer will work in a dynamic organization in our Noblesville, Indiana location. This technical writer will support the documentation for a new product coming into production in a few years. The goal is to have a submition to the FDA by August, and will with more products coming down the pipeline this will be ongoing work for them.

Must Haves:

1. Bachelors Degree in Engineering or related

2. 3 years of Technical Writing experience

3. Experience with GMP / cGMP regulations

Essential Functions

-Utilize technical writing strategies to ensure content of documentation is clear, concise, and complete.

-Author and revise technical documentation including facility and equipment SOPs, batch records, specifications, and training documents.

-Author and manage change controls as necessary to implement new procedures as well as revisions to documentation and SOPs to facilitate launch of new products.

-Participate in process and equipment testing to learn systems being documented.

-Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.

-Coordinate with operations, R&D, and quality representatives to ensure all project documentation requirements are achieved.

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

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.