Sr. Associate I, Quality Engineering

Biogen • Durham, NC

104d • $79,000 - $103,000

About The Position

The Quality Engineering (QE) Senior Associate I is responsible for the oversight of key functional, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The QE Senior Associate I will perform all duties in a manner consistent with site and corporate policies, cGMPs, safety, environmental and human resources policies and procedures and be proficient in their understanding of the Biogen Quality Systems and apply that knowledge in coaching and continuous improvement for all Quality Systems cross-functionally. The QE Senior Associate I will provide quality oversight of Engineering, Manufacturing, Maintenance and Facilities teams to ensure compliance with Biogen and industry cGMP standards. Additionally, the Associate may support internal and external inspections, assess, and approve discrepancies from site, corporate, and regulatory guidance. The QE Senior Associate I may also support the Manager in activities related to interviewing, and training of employees, providing feedback for personnel development and providing effective and timely decision making for issues related to systems, maintenance, or facility events.

Requirements

• Bachelor's Degree in Engineering or related Life Science or Technical discipline with 4+ years of relevant industry experience
• Thorough knowledge of FDA/EMA regulations including Current Good Manufacturing Practices (cGMPs) and International Council for Harmonization (ICH) guidelines
• Thorough Knowledge of Quality Engineering Systems (Facilities, Utilities, Maintenance, Engineering, Validation, and Automation)
• Experience in investigations, change controls, and CAPAs processes system knowledge
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to effectively communicate and collaborate with technical and senior management staff
• Experience in managing multiple, competing priorities in a fast-paced environment and dealing with ambiguity
• Demonstrated troubleshooting and strong problem-solving skills and the ability to develop innovative/creative solutions to issues of moderate or high complexity

Nice To Haves

• Thorough knowledge and/or previous experience with cGMP Drug Substance or Drug Product Manufacturing environments
• Ability to evaluate compliance issues and interact with regulatory inspectors
• Experience in QA oversight of manufacturing, analytical and engineering activities
• General knowledge of Project Management competencies obtained through relevant PM training or experience
• General knowledge of industry best practices including ISPE Baseline Guide 5, GAMP5 and ASTM E-2500
• Experience in Engineering and/or Validation (Equipment, Cleaning, Computerized Systems)

Responsibilities

• Review and approval of facility, utility, equipment, analytical instruments and automation lifecycle documentation including; User Requirements, Specifications, Drawings, Risk Assessments, Test Protocols, Deviations, Reports, Procedures and Periodic Reviews
• Review and approval of changes affecting validated analytical instruments, manufacturing processes, equipment, facility, utility, automation systems, material/components, and business processes associated with IT GMP computerized systems
• Provide cGMP guidance and quality risk management support of manufacturing on the floor issues with equipment or systems, including review and approval of deviations and Corrective/Preventive Actions (CAPAs)
• Support the site changeover program by providing oversight of multi-product equipment inspection and release including the review of changeover documentation, sampling, elastomer replacement, carry-over calculations, engineering configuration, summary reports and equipment release
• Support site capital projects by providing GMP guidance, risk management input and quality oversight during shut down planning, release and other major equipment/facility improvements
• Review and approval of GMP Preventive/Corrective maintenance work as applicable
• Lead investigations and CAPAs including driving Continuous Improvement initiatives
• Proactive identification and resolution of both technical and compliance issues/gaps
• Develop and implement aspects of various Quality Systems/System Improvements
• Other duties as assigned

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree