- Review and approve 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 approve 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 approve GMP Preventive/Corrective maintenance work as applicable.
- Proactive identification and resolution of both technical and compliance issues/gaps
- Develop and implement aspects of various Quality Systems/System Improvements.
- Bachelor's Degree, preferably in Engineering, Life Sciences or related Technical discipline.
- 3-5 years of relevant industry experience.
- Thorough knowledge of FDA/EMA regulations including Current Good Manufacturing Practices (cGMPs) and International Council for Harmonization (ICH) guidelines.
- Strong oral and written communication skills; ability to communicate with management and peers effectively.
- Ability to multi-task, coordinate multiple activities in parallel and deal with ambiguity.
- Demonstrated troubleshooting and strong problem-solving skills and the ability to develop innovative/creative solutions to issues of moderate complexity.
- Thorough knowledge and/or previous experience with cGMP Drug Substance or Drug Product Manufacturing environments.
- Experience in Engineering and/or Validation (Equipment, Cleaning, Computerized Systems).
- Experience with Quality Systems oversight and development.
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Associate III, Quality Engineering - Research Triangle Park, United States - Biogen Idec
Description
Job Description
About the Role
The Quality Engineering (QE) Associate III 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 Associate III 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 System cross-functionally.
What You'll Do
You are a motivated QA expert with sound Drug Manufacturing/Engineering experience/knowledge who is capable of being flexible with changing priorities. You are detailed oriented, a strong critical thinker and can work across multiple levels of the organization. You are truly a team player, knowing that when the team succeeds, we all succeed. You have a high level of personal accountability and are able to constructively hold peers and stakeholders accountable to their commitments.
Qualifications
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.
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 E-Verify Employer in the United States.
