Senior Manager-Engineering, Facilities, EHS

Location: Austin, TX
Department: Azzur Austin, LLC

Job Description

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.  All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. 

Job Description:

The Senior Manager, Engineering, Facilities, EHS & Safety Operations, provides support to all departments by performing and/or coordinating engineering, facilities, EHS & validation activities in accordance with FDA and other applicable regulatory requirements. The incumbent in this position is responsible for coordinating facility design/renovations, equipment implementation, construction, commissioning, utility systems operations and EHS activities as well as interact with all departments as required to maintain timelines and revenue generation. Routinely report on maintenance, quality and compliance issues.


Responsibilities:

  • Responsible for the overall direction, coordination, and evaluation of the facility unit.
  • Carries out supervisory responsibilities in accordance with the organization's policies, procedures, and applicable laws.
  • Managing clean room facilities including HVAC, Security Systems, RTU's, ACH, DP, Chilled water supply, laminar air flow, pharma grade gas supply systems, utilities, etc.
  • Construction and Major GxP Project initiatives
  • Calibration management and controls - CMMS (Computerized Maintenance Mgmt. System)
  • Routine planned and unplanned maintenance management - CMMS knowledge
  • Environmental control and monitoring - Building Management Systems (BMS, BAS)
  • Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
  • Equipment/ system lifecycle management and oversight (CMMS)
  • Experience interacting with FDA and other global agencies
  • Primary contact for after-hours Building Automation System call-out alarms.
  • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
  • Develop work plans, assign tasks, and supervise team(s).
  • Coordinates and directs the design, planning, construction, maintenance, and alteration of equipment, machinery, buildings and other facilities.
  • Ensures compliance with environmental regulations and works to reduce physical hazards in the facility by performing the following duties personally or through subordinates.
  • Strong knowledge of current industry trends and has the ability to use the latest technologies in managing the facility.
  • Experience with regulatory requirements and guidelines for therapeutic proteins, vaccines, monoclonal antibodies and Cell and Gene Therapy products is a significant plus.
  • Experience with Environmental Health and Safety (EHS) is a significant plus.

Qualifications:

  • Bachelor of Sciences degree in Engineering or related fields and 10+ years of experience as a biotech or pharmaceutical facility or process engineer within a GMP environment.
  • Must have hands-on experience in some of the following areas: GMP facility conceptual design, detailed engineering, construction, commissioning, validation, calibration, and maintenance.
  • Good understanding of FDA regulations (biologics or drugs).
  • Project Management Experience.
  • Detail-oriented with good verbal and written communications skills; demonstrated ability to manage multiple projects/tasks.
  • Ability to analyze data for accuracy and correctly interpret results.
  • Microsoft Office and AutoCAD experience
  • Building Management (Automation) system experience.
  • Familiar with federal, state and local government work safety regulations (eg. BMBL, USDA, CDC, OHSA, and other relevant work and safety guidelines) and experienced with the duties of being a safety representative.
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