Job Description

ABOUT THIS ROLE

Biogen’s Visual Inspection Manufaturing Associate is a member of our Parenteral Operations and is a highly detailed oriented candidate with excellent documentation skills and troubleshooting abilities.  The incumbent will perform and document daily manufacturing operations in a cGMP environment that involves operation of process equipment, execution of validation protocols, creating/revising cGMP documents and other assignments.

WHAT YOU’LL DO

• Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system.  Coordinates and/or leads process steps as required.
• Documents/Records and Reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Revises or creates documents as instructed. Key documentation includes batch records, SLRs, and equipment logbooks.
• Investigations deviations, develops and implements corrective and preventative actions as required by supervisor.
• Actively participates in training activities, managing their individual training plan.  Trains other associates as required.

WHO YOU ARE

If you are a highly detailed, focused individual that enjoys problem solving and team work, you could be a great fit for our manufacturing team!  You’ll have the opportunity to collaborate and innovate with a group of individuals who are passionate about saving lives.

Qualifications

REQUIRED EDUCATION / EXPERIENCE

MANUFACTURING ASSOCIATE III: 

• High school diploma (or equivalent) in addition to 1.5 years of direct experience/3 years of related experience OR 
• BioWork Certificate or Associate’s Degree in addition to 1 year of direct experience/2.5 years of related experience OR
• Bachelor’s degree with 6 months of direct experience/2 years of related experience

REQUIRED SKILLS

• Effectively contribute in a dynamic team environment
• Ability to interpret and apply GMP knowledge
• Excellent oral and written communications skills, and analytical and organizational skills.
• Willing to work evenings and weekends to accommodate production schedules.

*Please note that all selected candidates must have 20/20 vision with or without corrective lenses/contacts and pass a color vision testing for this role.

PREFERRED SKILLS

• Targeted biopharmaceutical training (Bioworks or equivalent) and/or experience in a regulated environment or military training
• Experience with process automation systems (i.e. DeltaV).
• Proficient in Window based software. Ability to adapt to changing software programs.
• EXPERIENCE PERFORMING MANUAL VISUAL INSPECTION ON DRUG PRODUCT VIALS IS HIGHLY PREFERRED
• EXPERIENCE WORKING WITH AUTOMATED VISUAL INSPECTION EQUIPMENT IS HIGHLY PREFERRED
• EXPERIENCE WORKING WITH AUTOMATED PACKAGING EQUIPMENT IN A PHARMA ENVIRONMENT IS HIGHLY PREFERRED
• ABILITY TO TROUBLESHOOT ISSUES ON EQUIPMENT

Additional Information

WHY BIOGEN?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.