Department: Azzur Cleanrooms-On-Demand Burlington LLC
Provide Engineering and Facility support to the Operations Team including:
- Provide engineering support to existing and/or new equipment and facility assets throughout their life cycle. Typical activities include:
- Equipment validation/qualification including generation and execution of IQ,OQ,PQ Protocols
- Equipment maintenance
- Equipment calibration
- User Requirements Specifications
- Change Controls
- Collect, analyze and report data
- Support and/or manage capital projects
- Create and/or revise Standard Operating Procedures (SOPs)
- Participate in, support and/or lead Quality Investigations, Root Cause Analysis and CAPA Implementation
- Participate in, support and/or lead Risk Assessments including FMEAs
- Assist with materials management activities including shipping, receiving and material restocking
- Assist with various facility activities including site and asset maintenance
- Assist with scheduling, operations management and enforcement of facility regulations
- Handling multiple responsibilities and job tasks (multi-tasking) as needed.
- Demonstrating attention to detail.
- Flexibility with work requirements, work environment and fast-paced/changing job needs.
Promoting teamwork by:
- Collaborating with co-workers.
- Leading team meetings as required.
- Meeting individual company goals as established.
- Establishing rapport and maintaining positive communication with others,
- Demonstrating respect, support, cooperation and flexibility with changes in schedule or priority.
- Adhering to company and department policies.
- Bachelor’s Degree
- Bachelor’s Degree with a study concentration in a scientific discipline
Required Work Experience:
- 1 yr experience as a technical contributor and/or in project management
- 3 yrs experience as a technical contributor and/or in project management
- Experience with capital projects and budget management, financing and related activities
- Experience with facility, utilities, equipment and system (FUSE) qualification
- Experience working in cGMP environment of Pharmaceutical or Medical Device industry
- Facilities, Utilities, Equipment and Manufacturing systems
- Microsoft Word, Excel, PowerPoint
Skills (incl.Typical Mental Demands):
Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:
- Computer skills, basic engineering and mathematical skills, use of spreadsheets
Fulltime Employment with Azzur can offer you:
- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Company provided laptop
Who we are:
Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with consulting, facility solutions, engineering, validation, IT, technical, training, COD, laboratory services, and solutions they need to remain innovative and competitive.
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages 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.