Senior Quality Engineer, Quality Assurance*
- Gaithersburg, Maryland
- Work experience
- Quality Management, Quality Assurance
Senior Quality Engineer, Quality Assurance *
This position is based in Gaithersburg, MD at our newly formed clinical manufacturing site for BioNTech US. Together with the BioNTech US North American Headquarters in Cambridge, MA, both the Gaithersburg and Cambridge sites are an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies that expects to experience significant growth in the near future. BioNTech US is a subsidiary of BioNTech SE with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
BioNTech is seeking an experienced, collaborative, and self-driven Senior Quality Engineer with focus on Quality Risk Management. This position has the responsibility to support, facilitate, or lead the Quality Risk Management program at BioNTech’s center of excellence for clinical Cell-Therapy manufacturing operations in Gaithersburg, MD. The Senior Quality Engineer will serve as the Risk Management and data integrity subject matter expert for the site, as well as a liaison with corporate Quality to support continuous improvement of the quality management system, tech transfer activities for new products, and validation activities for the site.
Here, you’ll achieve greatness.
- Provide in-depth understanding and application of pharmaceutical quality risk management practices and phase appropriate approaches within GMP manufacturing, GMP Facilities, and GMP Quality Control. Demonstrate knowledge of pharmaceutical relevant standards, principles and best practices.
- Lead and guide cross functional teams in the use of available QRM tools, including HACCP, FMEA, PHA, and RR&F.
- Collaborate with other departments (e.g. quality control, quality assurance, manufacturing, facilities, product development,) to complete risk assessments and change impact assessments. Leads teams in identifying mitigations and ensuring traceability of identified mitigations.
- Support technology transfer activities by ensuring compliance to risk management and validation program and reviewing study protocols and reports.
- Lead data analytics program for the site, including evaluation of product data (e.g. process and/or product changes, deviations, CAPAs, complaints, etc.) for their impact to the current quality risk management files.
- Author and review quality risk management plans, reports, risk assessments, and supporting technical documents such as validation documentation and change control.
- Provides training and guidance for validation, facilities, utilities, equipment, software, data integrity, and risk management processes including suitable methods for documentation.
- Ensure that all procedures and work instructions for the Data Integrity, Risk Management, and Validation Programs are followed at the site level.
- Support work order, calibration, and maintenance programs at the site.
- Ensure periodic reviews of Risk Management Reports are performed according to schedule.
- Report status and progress of quality risk management activities or projects to management. Track, review and report metric information.
- Support site Quality Engineering efforts and perform other duties as assigned.
What you have to offer.
- Bachelor’s and minimum 8 years’ experience working within a pharmaceutical or FDA regulated environment.
- Minimum 4 years’ experience working in a Quality Engineering function
- Manage and follow-up on several projects and activities running in parallel.
- Demonstrated and effective written and verbal communication skills.
- Excellent technical writing experience in a regulatory environment. Must be detail oriented and exhibit a high degree of flexibility and initiative.
- Ability to function efficiently in a diverse, fast paced, changing environment.
- Must be able to work independently as well as part of a team.
- Ability to think critically and utilize troubleshooting and problem-solving skills.
- Advanced Degree
- Knowledge of global regulatory agencies’ requirements for Quality Risk Management and Quality Systems (ICH Q9, GAMP5, 21CFR 11/210/211, etc.).
- Demonstrated completion of risk assessments supporting GMP and Cell Therapy applications.
- Cell Therapy experience
- CQE and/or Six Sigma/Lean certification
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HRA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email email@example.com.
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!