Job Description

Our client, a leader in the pharmaceutical industry, is seeking a Facilities, Equipment and Validation Technical Writer to join their team. As a FEV Technical Writer, you will be part of the Facilities Engineering and Validation (FEV) department supporting various teams. The ideal candidate will have strong analytical skills, excellent communication abilities, and a collaborative mindset which will align successfully in the organization.

Job Title: Facilities, Equipment and Validation (FEV) Technical Writer

Location: Cambridge, Massachusetts

Pay Range: $50-56 per hour

What's the Job?

• Update, author, and review FEV standard operating procedures and controlled documents as a result of process improvements and CAPAs.
• Perform investigation activities and write deviation investigation reports for FEV departments.
• Collaborate with subject matter experts from other departments to ensure a cross-functional evaluation is completed and ensure alignment of GxP practices.
• Coordinate prompt event evaluation, investigation, closure, and follow-up of process/equipment discrepancies.
• Utilize various root cause analysis and problem-solving tools to determine the root cause of GxP deviations.

What's Needed?

• Bachelor’s degree, preferably in a scientific or engineering discipline.
• A minimum of 3-5 years of experience in a pharmaceutical or related industry.
• Strong understanding of cGMPs, FDA regulations, and pharmaceutical manufacturing processes.
• Demonstrated technical writing skills with the ability to communicate complex technical events clearly and accurately.
• Experience with SAP or similar deviation management systems, and Veeva or similar quality document systems.

What's in it for me?

• Opportunity to work in a dynamic and collaborative environment.
• Engagement in meaningful work that contributes to the quality and safety of pharmaceutical products.
• Professional growth and development opportunities within the organization.
• Chance to be part of a team that values continuous improvement and innovation.
• Competitive pay rate reflecting your skills and experience.

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells –creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.

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