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Company

Original Job Post

BioSpace · 2 days ago

QA Engineering - FUME

Durham, NC

Full-time

Hybrid

Senior Level

7+ years exp

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Comp. & Benefits

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Responsibilities

Act as a FUME SME, working with Global Facilities Delivery, Lilly project staff, Global CSQA, and selected service provider firms to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Lilly Global Quality System requirements into the design.

Interact with the other global, project and functional areas to coordinate design and start up activities to support the overall project and site schedule.

Consult with Network and Global quality groups including GQS and Global Quality as required to ensure a consistent and compliant approach is executed during the project and startup phase.

Provide technical and quality review and approval of project FUME system documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.

Provide quality oversight for the verification and qualification of facility, utility, and maintenance systems including review of test cases, test execution, discrepancy resolution, etc.

Work with the Site Compliance Manager to support the development of the vision and strategy for the overall site quality operation with focus on the FUME areas.

Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring of new Quality and other project staff.

Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.

Lead project initiatives needed in support of the project and Quality function.

Resolve or escalate any compliance issues to the project, site, and Quality Management.

Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start-up and ongoing quality oversight of site FUME systems including working as part of the site Utilities Process Team and Business Quality Assurance for local computer systems.

Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.

Participate in self-led inspections and provide support during internal/external regulatory inspections.

Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents).

Participate in continuous improvement projects to help improve productivity within the local process team or quality organization.

Qualification

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Pharmaceutical QAFUME ExperienceFUME Systems QualificationRegulations KnowledgeTechnical WritingProblem-SolvingInterpersonal InteractionCommunicationHSEGMP UtilitiesMaintenance SystemsSix SigmaLeanCQE CertificationProject ManagementAccountabilityFlexibility

Required

Bachelors degree in engineering, computer science, or another science related field preferred.

At least 7 years working in the pharmaceutical QA roles.

Previous Pharmaceutical FUME experience.

Experience with FUME systems qualification including regulations governing them.

Demonstrated strong oral and written communication and interpersonal interaction skills

Demonstrated strong technical writing skills.

Preferred

Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Previous facility or area start up experience.

Previous experience with GMP utilities including WFI, Clean Steam, Process Compressed Air.

Previous experience with Maintenance systems.

Six Sigma Green Belt or Lean Training/Experience.

CQE certification from the American Society for Quality (ASQ)

Ability to work 8 hour days – Monday through Friday

Ability to work overtime as required.

Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations and support of site FATs as required.

The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment will the ability to periodically work remotely based on the project phase and site activities.

Position may require a short duration assignment of 1-2 months in Indianapolis to establish global contacts.