Sr Associate I Quality Control Systems Analytical Instrument Validation

This is a full time on site position with MF business hours

About This Role 

The Sr. Associate I position will serve within the Global QC Instrument and Equipment Strategy team. The Global QC Instrument and Equipment Strategy team is responsible for: (1) leading the harmonization effort of QC and MFG analytical equipment and instrument systems across sites (2) providing project management oversight for qualification validation decommissioning and integration with computer systems for instruments and equipment (3) supporting system administration activities during validation and serve as backup system administrator (when designated) when system is released for production use (4) managing the annual CAPEX budgeting and purchasing process and (5) overseeing the lifecycle management of QC and MFG instruments and equipment.  The Sr. Associate I will coordinate projects & deliverables and ensure proper administration and adherence to all Biogen policies and procedures. Additional responsibilities include writing and reviewing technical documents scheduling and balancing of workload with respect to equipment / instrument availability prioritization of projects adherence to all regulatory licenses and regulations interfacing with key Quality IT validation metrology & vendor representatives writing/coordination and review of operation maintenance and system administration procedures for all QC and MFG analytical equipment/instrumentation. 

WhatYoullDo 

• Lead validation/qualification projects for QC laboratory and MFG equipment instruments software applications and computer systems per applicable procedures. Utilize indepth/technical knowledge to review approve and execute system life cycle documentation including VP RRA RS IOPQ protocols decommissioning protocols other compliance related protocols/reports change control requests validation protocols/reports as applicable. 
• Assist with and plan training for team and supports completion of projects to milestones. 
• Ensure compliance with platform procedures and Global QC vision (global harmonization). 
• Plan implement and direct core functions of teams related to equipment/instrument purchase (eCAF and Purchase Requisitions) maintenance and implementation or decommissioning projects; provide system administration support during validation technical support during routine use as well as facilitation of investigations/compliance tasks.   
• Coordinate QC support activities/projects related to instrumentation/equipment with other departments & key contacts (internally/externally); provide updates to QC management. 
• Support and help to design effective laboratory systems/life cycle to ensure system/data integrity of all laboratory instrumentation/equipment programs.  
• Participate in a leadership or membership role for site crossfunctional teams as a representative of the QC laboratories. 
• Provides technical guidance to document authors (junior team members QC lab SMEs or consultants). 
• Other duties as assigned

Qualifications :

Required Skills

• Bachelors degree in Life Science Computer Science or Engineering with a minimum of 4 years of quality experience in a pharmaceutical or biotech manufacturing environment
• Technical knowledge regarding QC analytical equipment and instrument systems lab methodology (as appropriate)
• Demonstrated strong oral and written communication skills; ability to communicate with management peers and subordinates effectively; strong organizational and project management skills; ability to multitask and coordinate multiple activities in parallel; demonstrated problem solving skills; demonstrated instrument/computer system troubleshooting skills.   
• Knowledge of FDA/EMEA regulations including 21CFR parts 210/211 (GMP) EudraLex Vol. 4 (EU GMP) 21CFR Part 11 Annex 11   
• Skilled in validation lifecycle (CSV SDLC) documentation creation and review including: GxP Assessments Validation Plans Risk Assessments Data Integrity Assessments Requirements/Design Specifications IQ/OQ/PQ Protocols Reports and Standard Operating Procedures (SOPs)
• Experience with managing the periodic and preventative maintenance of equipment/instruments and maintaining the validated state of analytical equipment and instruments through change control and regularly scheduled periodic review
• Knowledge of Data Integrity principles

Preferred Skills

• Working knowledge of GAMP 5 for GxP Computerized Systems and/or USP <1058> Analytical Instrument Qualification
• Experience with QUMAS DocCompliance KNEAT TrackWise NuGenesis SDMS MS Sharepoint
• Familiarity with lab applications such as LabWare LIMS Empower CDS and vendorsupplied instrument control and data analysis software commonly used in QC laboratories in the pharmaceutical industry

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.