In this role you will be responsible for performing and documenting daily manufacturing operations in a cGMP environment. This involves operation of process equipment, execution of validation protocols, creating/ revising cGMP documents and other assignments. Applicants will be highly detailed oriented with excellent documentation skills. Applicants will become trained and skilled at most or all unit operations in their area, often leading the execution of procedures, and performs most functions with minimal supervision.

• Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record and control system. May coordinate or lead process steps as requested

• 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.

• Actively participates in training activities, managing their individual training plan. Trains other associates as required.

• Executes applicable documentation and/or protocols with minimal supervision/direction of others.

*LI-POT7

We are interested in hearing from candidates with a proven track record of success in the following areas:

• Targeted biopharmaceutical training (Bio-works or equivalent) and/or related military training also preferred

• Experience in fill finish, compounding, component preparation, and working with filling isolators is highly desired

• Detailed oriented with excellent documentation skills

• Strong peer and team leadership skills

• Adaptable to changing needs and demands, comfortable navigating in a changing environment

• Comfortable with ambiguity; quickly understands the needs based on the situation at hand

• Influencing and leading a positive attitude throughout team

• Ability to communicate clearly and effectively to all levels of the organization

• Ability to interact with others in a professional and courteous manner in accordance with Biogen’s Core Behaviors

• Capable to work a 12-hour shift, both day shift or night shift

• Ability to lift up to 50lbs and stand for up to 3 hours at a time is required

Work Requirements

• The normal work requirements are 12 working hours per day, including yet not limited to shift work and schedule changes.

• The incumbent may be required to work on holidays, weekends or alternate shifts as required, and is expected to be attired in plant uniform and present at the daily shift exchange as directed by supervision.

• The incumbent is required to be able to adjust focus and talk and listen to perform the duties of the position.  The noise level is normally loud.

• The incumbent at times is required to work near toxic or caustic chemicals.

Education :

We require a minimum of a high school diploma or equivalent, though Bachelor’s degrees are preferred

All your information will be kept confidential according to EEO guidelines.