High School Diploma Required. Bachelor's degree in engineering or Life Sciences or equivalent experience preferred.
Minimum of six (6) years of experience in Facilities operations.
Minimum of five (5) years of cGMP experience required
Minimum of 1-year of experience in personnel management experience.
Familiarity with cGMP requirements related to pharmaceutical production facilities and utilities; knowledge of relevant sections of 21 CFR parts 210 and 211.
Tactical expertise in Facilities coordination. Ability to apply knowledge of facility and utility operation with guidance from engineering and facilities management.
Has demonstrated ability to follow detailed directions in a GMP facility environment and has superior good documentation practices.
Preferred:
Exceptional organizational skills and attention to detail
Excellent interpersonal and communication skills, and the ability to communicate well orally and in writing
Proficiency in MS Office including Word, Excel, and Smartsheet
Team oriented and ability to work collaboratively with others
Highly attentive and organized with documentation
Ability to work in a dynamic, fast paced work environment
Honesty, integrity, respect and courtesy with all colleagues
The base salary hiring range for this position is ($76,000 to $85,500) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geograp
Benefits
Vision insurancePerformance bonus
Additional Information
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
JOB DESCRIPTION:
Position Title : Facilities Maintenance Supervisor
Location: San Diego, CA
Department: Facilities/Maintenance Supervisor
Reporting To: Sr. Manager, Facilities
Responsible For (Staff): Yes
The Facilities Maintenance Supervisor will utilize their combined technical and GMP experience to align facilities department workload and priorities with company and departmental needs. The Facilities Maintenance Supervisors' primary responsibilities include supervision of Facilities Maintenance Specialist direct reports, coordinating maintenance activities with technicians, end users, and service providers, and responding to facility, utility and equipment alarms in a timely and compliant manner. The Facilities Maintenance Supervisor will work closely with Facilities team members to ensure that maintenance is performed properly and on time in support of GMP production of sterile injectable drug products. In addition, the position will play a large supporting role in departmental initiatives for continuous improvement. The Facilities Maintenance Supervisor will also contribute as a subject matter expert (SME) during regulatory and client audits.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Leads training programs for the Facilities Maintenance team; leads by example and mentors team members.
Coordinates preventive and corrective maintenance for cGMP compliance; completes all associated documentation accurately while collaborating with Manufacturing and QA for scheduling and closure.
Writes and reviews Standard Operating Procedures (SOPs), Maintenance Forms, Change Controls, and Deviation Reports as appropriate, using MasterControl electronic document control system.
Assigns and tracks maintenance work to Facilities Maintenance staff.
Leads deviation investigations as a subject matter expert (SME).
May work closely with Project Managers and Quality Assurance on client-facing projects such as facility tours.
Works with service providers to request quotes and schedule activities; facilitates work schedules to meet customer needs.
Schedules annual shutdown activities with impacted departments and service providers.
Participates in continuous improvement initiatives to improve quality, compliance, and business efficiency.
Local area travel between facilities to support all functional areas.
Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices
Fosters a safe and environmentally sustainable workplace by ensuring compliance with all PCI EHS policies and procedures.
Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting and performance management
Maintains employee work schedules
Provides oversight and direction to employees in accordance with PCI Pharma Services policies and procedures