Instrument & Calibration Lead - Facilities*
- Gaithersburg, Maryland
- Work experience
Instrument & Calibration 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 Instrument & Calibration Lead based in our Gaithersburg, MD site, who will be responsible for the following; the instrumentation, calibration and preventive maintenance program for the site. Schedules the daily activities of Instrumentation & Calibration Technicians in the maintenance, repair, calibration of equipment and/or mechanical, electrical systems in respective area of responsibility, ensuring that Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements are followed. Oversee the installation, calibration, troubleshooting, repair, and modification to process control systems, electromechanical, and pneumatic control devices for manufacturing applications and utility support systems.
Here, you’ll achieve greatness.
- Supervises Instrumentation & Calibration Technicians, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
- Maintain a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required
- Maintain accurate assets record, always keeping equipment and systems cGMP compliant.
- Continuously evaluate instrumentation calibration practices to eliminate nonproductive activities and implement productivity enhancements
- Procures spare parts, labor, special tools, calibration equipment, contracts, documentation and equipment availability for work execution.
- Function as the administrator of the CMMS system for the system, overseeing all assets lifecycle records.
- Tracks KPI for work order completion and non-conformance trending, seeking resolution with assets owners in accordance with planned schedule and business priority
What you have to offer.
- Minimum requirements; 8 plus years of relevant experience and a high school diploma.
- Current Leaving Certificate and Trades Certificate GSL.
- Works independently and make sound judgments regarding work methods and tools
- Must have great communication skills and is able to deliver job expectations, coaching, training, recruiting, assigning tasks and ensuring reliability of facilities systems.
- Be proficient in ISA standards and practices for instrumentation
- Possesses a mechanical acumen including HVAC, Purified Water system, facilities utilities, P&ID’s, schematics and equipment specifications is a must.
- Be forward thinking the ability to work with system & technical metrics, identify variances & deficiencies while improving maintenance program and performance.
- Have an understanding of quality systems; Change Control, Deviations, CAPA’s, Audits activities, Computerized Maintenance Management Systems required.
Preferred requirements; Previous experience in biotech or pharmaceuticals industry, previous experience working in highly regulated manufacturing environments. Control automation and PLC experience
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!