|Date Posted||April 26, 2022|
Trades & Services
Summary: The primary job responsibilities of this position are to ensure clean room facilities, classified common areas and manufacturing suites (clean rooms) are cleaned, decontaminated, and disinfected according to established cGMP requirements. Responsible for administrative duties, reports, record keeping, material and supplies management, coordination of personnel work activities, troubleshooting, scheduling, and employee performance. Must be flexible to respond to changing priorities and handle changing workflow, including working on multiple projects at multiple sites and/or a flexible schedule as directed by the Shift Operations Manager.
Must be able to work effectively and efficiently in a team-oriented environment and be able to interact with internal departments to improve safety, maintenance, efficiency, and productivity. Adhere to and develop/improve department SOPs, quality compliance GMPs, and other established procedures.
- Provide leadership and coordination to a team of up to eight (8) Central Services Technicians (FDBT employees and/or contractors).
- Responsible for managing time and attendance tracking for Central Services Technicians.
- Ensures training is accurate and kept updated. Complete training records in a timely manner.
- Assigns duties and conducts employee performance reviews and routine weekly feedback sessions.
- Responsible for working with the coordinator to ensure resources are available and scheduled to cover all planned cleaning activities for GMP and non-GMP spaces.
- Adjust to schedule changes, work overtime as necessary, and be willing to support the others as needed. Be willing to adjust workload to accommodate rush requests.
- Track EM hits and work with Technicians to determine possible causes and preventative actions.
- Provide exceptional internal customer service. Immediately address any customer inquiries and requests. Report any customer issues immediately.
- Ensure technicians are receiving, consuming in SAP, and stocking gowning and cleaning supplies as needed.
- Promotes and complies with all FDBT EH&S policies, OSHA, and any other safety requirements, equipment procedures, and chemical handling guidelines.
- Trains Technicians on appropriate safety standards and protective personal equipment requirements.
- Ensure Technicians are wearing PPE while performing the job and report any ongoing noncompliance to manager and EH&S.
- Supports and enforces company policies, practices and GMP procedures.
- Accurately review documentation per established procedures.
- Review all data fields, supplies used, labels, and calculations to ensure accuracy and completion per established procedures.
- Report any ongoing errors to manager.
- Mechanical aptitude with ability to understand and conduct light maintenance on cleaning equipment and to comply with quality procedures and change controls.
- Submits work requests for Clean Room equipment maintenance and repairs when needed.
- Responsible for meeting with service vendors and suppliers.
- Responsible for the continuous development and implementation of process and equipment improvements and efficiencies. Report any pain points escalated by Technicians to manager
- Perform all other duties as assigned.
Required Skills & Abilities:
- Demonstrated leadership, coaching and mentoring skills.
- Demonstrated experience in training others to perform and maintain cGMP standards.
- Excellent skills with Microsoft Office applications.
- Must have flexible work hours, and be willing to work outside of normal, scheduled hours, as necessary. Must be able to work alternative shift hours and weekends as required to align with manufacturing and quality activities.
- Excellent self-discipline and attention to detail.
- Must have exceptional planning and organizational skills, excellent oral and written communication skills, and be proactive in interfacing with colleagues in various roles and functions throughout the site.
- Demonstrated ability to work with teams and collaborate with others.
- Excellent problem-solving skills.
- Must be a self-starter with the ability to work with minimal supervision.
- Must have a sound understanding of sanitation and workplace housekeeping, especially in a cGMP environment.
- Must have demonstrated understanding of hazard awareness, accident prevention, and safety compliance.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Must be able work weekends, off-shifts, and overtime as required.
- Attendance is mandatory.
- No make-up or jewelry can be worn when working in the clean room environment.
- Expected to be on feet standing or walking for up to 90% of shift.
- Work on and around pressurized tanks, housings and equipment, which are connected by piping and pumps and serviced by pressurized steam, water, air and cleaning/sanitizing chemicals systems.
- Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers multiple times per shift.
- Must handle and work with hazardous materials and chemicals per OSHA guidelines.
- Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online computer systems.
- Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand motions.
- Must be able to lift up to 40 pounds
- Must be able to work wearing a PAPR (air-purifying respirator)
- Associates Degree with six (6) years cleaning or janitorial experience of which two (2) years must have been as a lead or supervisor; or
- High School Diploma with ten (10) years cleaning or janitorial experience of which two (2) years must have been as a lead or supervisor.
- Previous experience in a GLP or GMP environment.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail or call .