Commissioning & Qualification Lead - Facilities*
- Gaithersburg, Maryland
- Work experience
- Service (other)
Commissioning & Qualification Lead - Facilities*
BioNTech is a Germany-based biotechnology company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company's oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.
BioNTech is seeking a highly-motivated Commissioning & Qualification Lead - Facilities to support and lead, maintain a robust qualification and quality program to support and maintain in a qualified and compliance state the facility, including process, laboratories and utilities equipment. Provide Validation oversight of equipment, facility and utility qualification, computer system validation, cleaning validation, and shipping validation, among others. Create and execute commissioning, qualification, and validation protocols (CP/IQ/OQ/PQ), recognizing specific parameters, sampling and tests, including identification and resolution of exceptional conditions of equipment, facilities, utilities and systems.
Here, you’ll achieve greatness.
- Ensure validation protocols and processes comply with global regulatory requirements. Correctly employ industry best practices that will withstand regulatory inspections by regulatory authorities.
- Assists in equipment selection, specification, and the application of a risk-based approach when determining qualification strategies.
- Supports Computerized System Validation (CSV) documents including computerized system Risk Assessments, Validation Project Plans, User Acceptance Tests and Reports.
- Ensure compliance and implement best practices as appropriate
- Develop and review technical documentation including specifications, protocols & summary reports, lifecycle documentation, other testing, and validation SOPs.
- Perform temperature mapping and other miscellaneous validation activities.
- Manage contractors supporting CSV, equipment and utility system commissioning, qualification, and validation.
- Support process and method transfer validation activities, as necessary by manufacturing and Quality Control labs.
- Participates in internal audit/inspection
- Responsible for leading investigation, technical writing and implementation of corrective actions related to CAPAs, change control and deviation for manufacturing and GMP systems.
What you have to offer.
- Minimum requirements; Bachelor's degree in a technical, preferably an engineering or biological science discipline and 8 plus years pharmaceutical and/or biopharmaceutical industry experience.
- Experience leading a team
- Ability to write department operational/maintenance and engineering SOP’s
- Ability to read blueprints, control drawings and logic controls and BMS program language.
- Experience with Computerized Maintenance Management Systems and Building Management System.
- Experience work on mechanical, electrical, HVAC, boilers, water systems and compressed gases
- Excellent communications skills to explain information and influence others to secure successful implementation of Facilities and Engineering programs and directives as assigned.
- Work independently and make sound judgments regarding work methods and tools.
- Self-motivated with a strong sense of ownership in areas of responsibility
- Ability to adapt in a constantly evolving environment
- Self-starter with superior analysis and problem-solving skills ranging from simple to complex situations
- High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
- Proficient in MS Office suite
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 firstname.lastname@example.org.
*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!