33 Jobs in Devens, MA
Azzur Group is Hiring an Operations Specialist II Near Devens, MA
As you look to start your journey on the next cure that can heal patients and save lives, lack of space to manufacture and properly follow cGMP processes can be a major hurdle. To address the unique needs of start-ups in your position, Azzur Cleanrooms on Demand™ is here to support production for early-phase partners, helping you accelerate your time to market. Truly unique to the industry, our on-demand cleanrooms as a service include cGMP-compliant cleanroom space, warehousing, and materials management. This allows partners to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations (CMOs). Unlike working with a CMO, Azzur Cleanrooms on Demand™ mitigates risk, affording you full access and control to your IP, space, and activities. This is all backed by quality management consultants with decades of experience implementing phase-appropriate GMP for industry leaders.
The Operations Specialist II is responsible for providing engineering support to the installation, commissioning, validation, operation, and maintenance of the equipment and facilities at Azzur Cleanrooms on Demand™ (CoD) location in Devens MA.
Responsibilities
- Provide engineering support to existing and/or new equipment and facility assets throughout their life cycle.
- Equipment validation/qualification including generation and execution of IQ,OQ,PQ Protocols
- Equipment maintenance and calibration
- User Requirements Specifications
- Change Controls
- C ollect, analyze, and report data
- Support capital projects
- Create and/or revise Standard Operating Procedures (SOPs)
- Participate in and support Quality Investigations, Root Cause Analysis and CAPA Implementation
- Participate in and support Risk Assessments including FMEAs
Work Experience
- 2 years experience as a technical contributor and/or in project management; 4 years preferred
- 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
- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Company provided laptop
Job Summary
Full Time
Business Services
$51k-70k (estimate)
06/09/2024
07/07/2024
azzur.com
HATBORO, PA
200 - 500
2010
MARK O DONNELL
$50M - $200M
Business Services
Related Companies
About Azzur Group
From Discovery to Delivery, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on DemandTM facilities, to our labs, training centers, and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the worlds leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain. Vision: To be the premier choice of clients ...
and talent across our services. Mission: We will lead the healthcare and life science industries in innovative quality and compliance solutions from Discovery to Delivery. Core Values: Put others first Have courage to take action Take personal responsibility Have Fun!
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The job skills required for Operations Specialist II include Project Management, PowerPoint, etc. Having related job skills and expertise will give you an advantage when applying to be an Operations Specialist II. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Operations Specialist II. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Operations Specialist II positions, which can be used as a reference in future career path planning. As an Operations Specialist II, it can be promoted into senior positions as a Check Collections Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Operations Specialist II. You can explore the career advancement for an Operations Specialist II below and select your interested title to get hiring information.
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