Location: San Francisco, CA
Department: Azzur Consulting LLC
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Department: Azzur Consulting LLC
Job Description
Azzur Group is looking for mid-level Facility Engineer to join our growing team. Working with a multi-disciplinary team, the Facility Engineer ensures completion of project deliverables according to the established plan. In this hands-on role, the Engineer is the one of the key liaison between project stakeholders (client, company and direct reports), and will be responsible for the quality of work produced by their team. Experience with cGMP and FDA compliance is essential.
Essential Duties and Responsibilities
- Write technical documents associated with projects.
- Write engineering and design specifications (URS/FS/DS) for facility and utility systems.
- Perform (hands on) troubleshooting activities to ensure continuous utility support.
- Reviewing equipment lists, instrument lists, drawings, specifications, and submittals to ensure quality, accuracy, and completeness.
- Performing field walk downs to ensure installation meets design requirements.
- Identifying deficiencies of existing utility equipment and ensure correction in a timely manner.
Required Experience
- BS Engineering or related discipline.
- Minimum 5 years facility engineering experience in the pharmaceutical, medical device and/or biotechnology industry is required.
- Experience with HVAC and WFI systems is required.
- Strong utility and facility design and troubleshooting experience.
- Experience with FDA compliance and cGMP is required.
- Must be results oriented with several years of hands-on experience, familiar with industry concepts, practices, and procedures in a cGMP environment.
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Excellent verbal, oral, and technical writing communication skills.
- Proficient in Microsoft Word, Excel, Power Point, Project and able to quickly learn new computer applications.
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