Manager, Commissioning & Qualification - Engineering

Gaithersburg, US   |   full time   |   Job ID: 8842 

The Commissioning & Qualification Manager will lead and guides validation efforts, including the development and maintenance of the site Validation Master Plan of the site.  Key responsibilities involve leading the creation and execution of commissioning, qualification, and validation protocols (CP/IQ/OQ), as well as addressing exceptional conditions in equipment, facilities, utilities, and systems. The role also includes managing Computerized System Validation (CSV) efforts of the site. The Commissioning & Qualification Manager will provide oversight, lead execution and work cross-functionally and in project teams to determine the extent of validation required for the implementation of new assets, conduct impact assessments for proposed changes to existing assets, and be responsible for the execution of BioNTech GB site re-qualification program.

Primary Responsibilities:

• Oversee the planning, execution, and documentation of validation activities for equipment, systems, instruments, and computerized systems for GMP operations.
• Owns and maintains a robust qualification and quality program to support and maintain in a qualified and compliance state the facility, including process, laboratories and utilities equipment.  
• Approve, review and generate as needed commissioning, qualification, and validation (CQV) protocols (CP/IQ/OQ/PQ), recognizing specific parameters, sampling and tests, including identification and resolution of exceptional conditions of equipment, facilities, utilities and systems.
• Approve, review and generate technical documentation as needed including specifications, lifecycle documentation and validation SOPs.
• 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.
• Ensure compliance with Computerized System Validation (CSV) requirements and documentation such as Risk Assessments, Validation Project Plans, User Acceptance Tests and Reports etc.
• Guide and lead temperature mapping and other miscellaneous validation activities.
• Lead and mentor the validation team, fostering a culture of excellence and continuous improvement.
• Manage contractors supporting CQV and CSV activities.
• Support process and method transfer validation activities, as necessary by manufacturing and Quality Control labs.
• Participates in internal audit/inspection
• Conduct risk assessments and develop mitigation strategies for validation projects.
• Develop and implement validation strategies and policies in alignment with regulatory requirements and company goals.
• Other Duties as assigned.

Requirements: 

• Minimum requirements include a bachelor’s degree in a technical, preferably an engineering or biological science discipline and 10+ years pharmaceutical and/or biopharmaceutical industry experience or MS degree in a technical, preferably an engineering or biological science discipline with 8 years’ experience in a pharmaceutical and/or biopharmaceutical industry experience
• Experience leading a team
• Ability to write department operational/maintenance and engineering SOP’s
• Experience with Computerized Maintenance Management Systems and Building Management System.
• Demonstrated attention to detail and ability to effectively manage own projects and priorities.
• Strong oral and written communication skills and an ability to communicate complex concepts in a concise, simplified manner.
• Ability to prioritize effectively and maintain adherence to project timelines and commitments with competing priorities.

Preferred Requirements:

• 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

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Your Benefits

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

…and more! More details to be shared.
 

Expected Pay Range: $130,000/year to $165,000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).  *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation’s capital. The city’s strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg’s manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.

Apply now - We look forward to your application!

Apply for our Gaithersburg, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.