Manufacturing Associate II - Visual Inspection

This position will work a four day ten hour shift 6a4p Monday to Thursday each week

About This Role

Manufacturing Associates perform processing steps and manufacturing support activities in our facilities in Research Triangle Park (RTP). These teams are the backbone of our operations each person playing a critical role in delivering our therapies to the patients who need them. This position will be in our Parenteral Filling operations and our teams operate across the following units:

Visual Inspection

What Youll Do

Execute daily manufacturing activities to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)

Document and record all cGMP data & information (including deviations) for processing steps and equipment activities. Create and revise key documentation like batch records SLRs and equipment logbooks

Help maintain a clean and safe work environment always focusing on audit readiness of process areas

Be a team player and leader; always showing up to contribute your energy and focus

Assist in investigations of procedural deviations

Adhere to aseptic gowning and operating procedures

Actively participate and lead in training and development initiatives both for personal growth and for that of your team members

Who You Are

You are someone developing a deep passion for doing work that furthers a mission to save lives. You have a high degree of demonstrated learning agility are energetic and love a fastpaced work environment where everything you do is incredibly impactful. Biomanufacturing is complex so you have the mental flexibility to be adaptable to whatever comes your way.

Qualifications :

Required

Bachelors Degree (STEM preferred) plus at least 6 months of directly transferrable experience OR

BioWorks Certificate or Associates Degree plus at least 1 year of directly transferrable experience OR

High School Diploma (or equivalent) plus at least 1.5 years of directly transferrable experience

Physical requirements

In order to ensure that all visual inspection tasks comply with FDA guidelines any employee that has visual inspection job responsibilities must undergo an initial visual exam before starting the position and an annual visual exam to ensure ongoing compliance with visual standards.  The employee must pass the visual exam and be able to detect small particles and imperfections with or without reasonable accommodations. 

Capable of working twelve (12) hour shifts in a predetermined schedule rotation

Ability to lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds

Strong desire to learn and grow quickly demonstrated experience employing learning agility

Adaptable to changing needs and demands comfortable navigating a dynamic environment

Strong communication skills

Additional Information :

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.