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Operations Engineer I

Location: Waltham, MA

Job Description

Description

Azzur Cleanrooms on Demand™ (COD) is looking for a Operation Engineer to perform and verify GMP activities to support clean room and raw material program operations at all COD facilities located in Waltham, MA.

Responsibilities:

--Generate GMP documentation used to support Clean room client start-up and ongoing manufacturing operations. Examples of these duties include:

  • Support the execution of equipment qualification and commissioning studies for shipping, facility utilities and equipment used in client process operations and in facility operations.
  • Execute protocols and help resolve protocol deviations/discrepancies, analyze study data and write summary reports.
  • Identify process improvements that enhance compliance and/or operational efficiency, such as reduction in non-value activities, elimination of wastes, and improvements in operational flow.

---Contribute to business unit continuous improvement projects’

Examples of support are:

  • Identifying and executing project actions to improve the Inventory Control System or the Computerized Maintenance Management System used to support Facility operations.

--Perform and verify Facility operations assignments per approved procedures and protocols:

Perform materials management, shipping and receiving, aseptic raw material sampling per an approved specification, inventory control assignments and various client required assignments. These duties ensure client and internal COD operations are performed in compliance with relevant site and client procedures and pertinent regulatory requirements. Typical duties include oversight and review of:

  • Shipments and documented according to site and client procedures.
  • Client material shipments in compliance with temperature control and chain of custody requirements.

--Maintain the facility in a state of audit readiness. Ensure operations are being performed correctly per approved procedures. Identify and implement process improvements.

  • Perform housekeeping and restocking duties. Review logbooks on a routine basis.
  • Ensure procedures are being followed as written for all COD personnel and clients.
  • Identify process improvements that enhance compliance and/or operational efficiency, such as reduction in non-value activities, elimination of wastes, and improvements in operational flow.

Requirements

 

  • Some experience in role or one with related job skills
  • 1-2 yrs experience in similar role
  • GMP experience is highly preferred
  • Raw Material handling and aseptic technique experience preferred
  • Cleanroom experience is highly preferred
  • Microsoft Office

Education:

  • Bachelor’s Degree or higher in a scientific discipline

Required Knowledge:

Skills (incl.Typical Mental Demands):

Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:

  • Computer skills, basic mathematical skills, use of spreadsheets, clear penmanship.

Benefits

  • Flexible PTO
  • Training and Development Opportunities
  • 401(k) match
  • Bonus Eligibility
  • Medical Benefits
  • Paid Holidays

At Azzur, we understand how to help companies in the health and life science industry bring their projects to life, and follow them from Discovery to Delivery™. We believe success is carefully calibrated, precisely executed, and thoroughly monitored. Our nationwide network of companies is dedicated to providing continuous service to customers in the pharmaceutical, biotechnology, medical device, diagnostics, biologics and clinical industry, as well as all HLS suppliers.

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 diverse culture, ethnicity, gender and age 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.