Quality Engineer I, Controlled Environment (Hybrid) - Merrimack, NH -

Job Function Summary:

A Quality Engineer, Controlled Environments, is responsible to provide engineering and technical support in the areas of Cleanroom Environmental Monitoring, Contamination Controls, and Microbiological Testing. This includes development, revision, organization, administration, and compliance of the company's routine Controlled Environment efficacy programs including Systems Qualification, Environmental Monitoring, and Biological Product Testing. A Quality Engineer, Controlled Environments, shall also perform tasks, as assigned, to support change control, CAPA activities, and other compliance activities related to the Controlled Environment and Contamination Control Programs.

Job Functions:

• Development, qualification, maintenance, and nonconformance analysis of a routine testing program for maintenance of a manufacturing environment suitable for the manufacture of medical devices. The program includes, but is not limited to, the following tests:

• Air pressure differential measurement
• Temperature and %RH measurement (where applicable)
• Air Particulate Testing
• Microbiological tests of system and testing waters
• Biological Air Testing
• Bioburden analysis (surface)
• Compressed Air and Nitrogen Testing.

Microbiological Testing as part of the sterilization assurance and contamination control program also include the following:

• Bacterial Endotoxin analysis of finished goods and in in-process components.
• Bioburden analysis (finished goods)

• Oversee and/or perform sampling for aforementioned test types as required.
• Oversee, perform and/or review controlled environment and microbiological test result data entry.
• Maintenance of contamination control, environmental monitoring, and bacterial endotoxin risk assessments.
• Ensure continued conformance to existing standards (e.g. ISO 14644 series, ISO 11737-1, and ANSI/AAMI ST72), perform gap analysis for new/revised standards/guidance documents, and maintain compliance by implementing changes to conform (where applicable) to conform to new/revised industry standards.
• Representing CE&S for Operations projects working towards optimizing the manufacturing workflow including equipment and work stream relocations.
• Representing CE&S in cross functional project teams working towards introducing new products lines or expanding existing lines.
• Development of Controlled Environment IQ/OQ/PQ protocols and reports to support facility and operation changes.
• Maintenance of Controlled Environment Requalification Program, including generation of protocols/reports.
• Generation and ownership of Controlled Environment, Contamination Control and Microbiological Testing CAPA Requests and CAPAs
• Representing CE&S in cross function CAPAs where necessary.
• Performance and/or supervision of additional departmental analysis, or tasks, including, but not limited to:
  
  
  
  • Writing, implementing, revising, and, or approving Standard Procedures (SPs), protocols, and reports relating to Controlled Environments.
  • Authoring, ensuring execution of and approving microbiological test method validations.
  • Generating Controlled Environment & Microbiological related content and controls within equipment relocation plans, part qualification, supplier change assessments, and design change quality plans.
  • Nonconformance technical support for controlled environment and product testing excursion events including root cause analysis and investigation.
  
  
  
  
• Development, maintenance, and execution of Environmental and Product Microbiological Testing Trend Analysis Programs
• Additional projects as assigned by Departmental Management.
• Assists in special projects as needed.
• Contributes to team effort by accomplishing related duties as requested.

Required Knowledge, Skills and Abilities:

• Highly organized with strong negotiation and communication skills.
• Detail oriented with ability to self review
• Familiarity with ISO Standards for Controlled Environments and Microbiological Testing
• Ability to create and revise technical documentation as well as author position pieces with minimal guidance

Minimum Requirements:

• A Bachelors' Degree in Engineering, Biology, Microbiology, Chemistry, or a related science and two years' experience in a medical device or pharmaceutical environment.
• Equivalent work experience shall be acceptable in place of education at the discretion of the Manager, CE&S.

Environmental/Safety/Physical Work Conditions:

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Duties are performed in an office environment.
• Duties are performed in a manufacturing/clean room environment.
• Personal protective equipment may be required as dictated by work environment.
• Some duties may be performed remotely.

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