Validation and Controls Lead*
- Gaithersburg, Maryland
- Work experience
- Production, manufacturing
- Quality Management, Quality Assurance
Validation and Controls Lead*
This position is based in Gaithersburg, MD at our newly formed research and 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.
Under the supervision of the Director of Facilities and Engineering, this position will be responsible for supporting all validation efforts, including the development and maintenance of the site Validation Master Plan. The role includes providing quality and technical direction to develop and maintain qualification studies to ensure that equipment and processes will satisfactorily meet the client and facility specifications for quality.
Here, you’ll achieve greatness.
- Create and execute commissioning, qualification, and validation protocols (CP/IQ/OQ/PQ), including identification and resolution of exceptional conditions of equipment, facilities, utilities and systems.
- 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 performing CSV, equipment and utility system commissioning, qualification, and validation.
- Support process and method transfer validation activities, as necessary by manufacturing and Quality Control labs;
- Perform investigations and implement corrective actions related to CAPAs and deviations;
- Participates in internal audit/inspection
- Identifies issues and performs routine trouble shooting on Automation controls associated to the EMS and BMS equipment and systems.
- Oversee the Building Management System to ensure the facilities, equipment and environmental systems are within specified ranges and operating systems are functioning properly.
- Locates and diagnoses failure, replaces defective components and performs basic troubleshooting using standard electronic equipment, detailed drawings, diagrams, sketches, specifications, prints, manuals and verbal and/or written instructions.
- Monitors deviations from systems specifications and works with Facilities staff to correct or resolve these discrepancies. May assist in calibrating and fine‐tuning controls.
- Ensure compliance with all applicable regulatory agencies including FDA, OSHA, DOH, EPA, Fire Department, city audits, Health Department, etc.
What you have to offer.
Minimum requirements; Bachelor’s degree in engineering, Life Sciences discipline or related field or equivalent experience, with 10+ years of facilities and maintenance operations experience in the biotechnology or pharmaceutical industry
- Experience in Building Management Systems, HVAC automation controls, energy management systems, or other related experience. Able to check and respond to and troubleshoot Equipment Monitoring System & Building Management Systems issues and alarms.
- Ability to read blueprints, control drawings and logic controls and BMS program language.
- Knowledge of HVAC network systems, including fiber optic networks and building management communication networks
- Experience with Computerized Maintenance Management Systems, and Building Management System.
- Have an understanding of quality systems; Change Control, Deviations, CAPA’s, and Audits activities.
- Experience work on mechanical, electrical, HVAC, boilers, water systems and compressed gases
- Experience with utilities, engineering, maintenance, computerized systems and validation activities in a GMP environment
- Experience with systems investigation and root cause analysis tools
- Work independently and make sound judgments regarding work methods and tools.
- Skilled at creating and delivering presentations
- Self-motivated with a strong sense of ownership in areas of responsibility
- Ability to adapt in a constantly evolving environment
- Ability to write department operational/maintenance and engineering SOP’s
- Self-starter with superior analysis and problem-solving skills ranging from simple to complex situations
- Proficient in MS Office suite
- Demonstrates proficiency in current Good Manufacturing Practices (GMPs).
- Excellent communications skills to explain information and influence others to secure successful implementation of Facilities and Engineering programs and directives as assigned.
- 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
- Willingness to think outside of the box and adapt best practices to our growing environment
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & FSA Spending Accounts
- Free COVID-19 Testing
- 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!