Facility and Cleanroom Specialist - Isotopia USA

Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. At our US headquarters in Indianapolis, we will be next door to our key customers, delivering our products just in time, each day, every day. We are seeking a highly motivated and detail-oriented Facility and Cleanroom Specialist to join our dynamic team. The Facility and Cleanroom Specialist will play a critical role in maintaining the integrity, cleanliness, safety, and regulatory compliance of cleanroom and facility environments and supports the manufacturing of high-quality radiopharmaceuticals products through the calibration and preventative maintenance program of critical equipment and systems. The specialist will work closely with manufacturing, quality assurance, and facilities, maintenance and engineering teams to uphold the highest standards in cleanliness and safety. The ideal candidate will have a keen eye for detail, excellent organizational and communication skills, and a strong commitment to cleanliness and maintenance.

Requirements

RESPONSIBILITIES:

• Coordinates with other departments to monitor and maintain the operational use of cleanroom facilities, manufacturing and quality control areas by ensuring the proper functionality, cleanliness and compliance with established Standard Operating Procedures (SOPs) and regulatory guidelines.

• Performs routine cleaning, sanitization, and disinfection of cleanroom areas and equipment as needed based on manufacturing schedules to establish aseptic conditions ensuring the product’s quality and the patient’s safety are uncompromised.

• Maintains proper functionality and readiness for use of cleanroom facilities, equipment, and systems through the calibration and preventative maintenance program. For example, the specialist will be responsible for replacing pre-filters and contemporaneously documenting the work was completed.

• Supports the environmental monitoring program of cleanroom areas by regularly conducting particle counting, microbial monitoring, and surface sampling to verify compliance with ISO classifications.

• Remediates issues in the facility, cleanrooms, manufacturing or quality control areas to reestablish integrity, cleanliness, safety, and / or regulatory compliance as identified.

• Monitor and control environmental conditions within cleanroom areas; specifically: temperature, humidity, air quality, and differential pressures. Identifies and reports any deviations to management and implements appropriate corrective actions.
• Resupplies gowning and personal protective equipment (PPE) in quality control and gowning room areas as needed.
• Responsible for the removal and disposal of waste in the manufacturing areas and quality control areas. Surveys all exiting waste for radioactive contamination then documents, handles, and determines disposal pathway per radiation safety procedures.
• Maintain accurate and up-to-date records of cleaning, environmental monitoring activities, and inventory of all radioactive waste held for decay.

• Familiarize with emergency response procedures and participate in drills and training exercises. Respond promptly and effectively to any cleanroom-related emergencies or incidents.
• Identify opportunities for process improvements, efficiency enhancements, and best practices within the cleanroom environment. Contribute to the development and implementation of new procedures and protocols.
• Other tasks and responsibilities assigned by management.

EDUCATION AND SKILLS:

• High school diploma or equivalent; additional technical education or certification in cleanroom operations, biosafety, or related fields preferred.
• Proven experience working in a cleanroom or controlled environment, preferably in the pharmaceutical or radiopharmaceutical industry is preferred.
• Understanding of aseptic techniques, cleanroom behaviors, and contamination control principles and familiarity with environmental monitoring equipment required.
• Excellent problem-solving skills and attention to detail are highly preferred.
• Knowledge of cGMP regulations, quality systems, and radiation safety practices a plus.
• Ability to follow SOPs exactly and consistently.
• Strong record keeping and organizational skills.
• Effective verbal and written communication skills are essential.
• Able to work effectively in a team environment and collaborate with cross-functional teams.
• Physical ability to stand for extended periods, bend, stoop, crouch, and lift heavy equipment up to 50 pounds as required.
• Comfortable working in scrubs, lab coats, cleanroom attire including but not limited to: gowns, full-body suits, gloves, respirators and masks.
• Proficient in basic computer applications and data entry.
• Flexibility to work in shifts and occasional off-hours or weekends as needed.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Short Term & Long Term Disability
• Training & Development
• Free Food & Snacks