General Job Description/Team Overview:
As part of a talented and highly motivated multi-disciplinary team advancing an exciting new approach to drug discovery, development, and manufacturing, the successful candidate will be part of a skilled Manufacturing team working to execute GMP production campaigns to supply the company’s clinical pipeline targets. The role will support the facility and engineering needs of GMP Cleanrooms, Research & Development labs, Process Development labs, and Quality Control labs. The Maintenance Technician will monitor, coordinate, and execute all functions in the areas of environmental health and safety, calibration and preventive maintenance, and facility construction and maintenance. The technician role will interface with technical personnel, administrative staff, and outside service vendors to ensure proper facility/lab performance. The level will be determined based upon the candidate’s education, skills, and/or related experience.
Primary Duties and Responsibilities (include but are not limited to):
• Repair and Service Equipment: Identify, troubleshoot, and arrange lab and manufacturing equipment to be repaired.
• Facility Operations: Ensure a high functioning infrastructure, coordinate renovations and/or new construction as needed, coordinate identification of upgrades and estimates. Responsible for maintenance of electrical systems, plumbing, HVAC, facility layout, telecommunication, GMP/GLP areas.
• Adhere to GDP requirements and document work through the work order system.
• Ability to gown into GMP areas (ISO 6, 7, & 8) and GMP aseptic areas (ISO 5) to perform work.
• Calibration and Preventive Maintenance: Organize, coordinate, and document the calibration and preventive maintenance programs; direct qualification and validation when appropriate.
• Environmental Safety: Organize, coordinate, and document the hazardous waste collection and disposal process; maintain and assist in safety programs and safety training; maintain safety equipment (i.e., Fire/Security Alarms, Fire extinguishers/sprinklers).
• Regulatory Compliance: Interface and coordinate safety inspections, permits, and employee training/safety programs; assist in ensuring cGxP compliance along with federal and state regulations and standards.
• Supervise contractors and vendors as needed. • Perform other duties as assigned.
• High school diploma with 8+ years’ experience or bachelor’s degree with 4+ years’ experience in facilities management or an equivalent combination of relevant education and experience.
• Safety training: hazardous waste training.
• Knowledge of and working respect for biosafety guidelines and procedures.
• Ensures project deadlines and performance standards are met.
• Operates both independently and as a team member depending on current company priorities.
• Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.
• Excellent organizational skills with attention to detail and accurate record keeping.
• General knowledge of Federal and State regulatory requirements in a GxP environment.
• High degree of discretion dealing with confidential information.
• Ability and willingness to work flexible hours when needed.
• Demonstrated ability to work independently and in a team environment.
• Excellent written, verbal, and interpersonal communication skills.
• Eligible to work in the U.S.
Job Type: Full-time
If you're interested in joining our Team, start by applying here and attaching your resume.