Associate Manufacturing Systems Engineer I

Quick Facts

• Role: Associate Manufacturing Systems Engineer I (Validation SME/technical lead)

• Focus: Validation strategy, documentation, equipment qualification, cleaning/sterilization validation, and validation maintenance

Description

Serve as a technical lead/SME responsible for developing and implementing the validation strategy at the North Carolina manufacturing facility. You will generate site validation documents (including the Validation Master Plan, validation plans, and equipment qualification protocols/reports) and drive milestones for autoclave performance qualification, cleaning validation, and validation maintenance. You will also support commissioning/qualification and collaborate cross-functionally to ensure overall validation requirements are met.

Responsibilities

• Provide support for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities at the site

• Collaborate with project leads with accountability for validation-related project results for commissioning and qualification of manufacturing process equipment

• Build cleaning/sterilization validation expertise, including generation/review/approval of cleaning validation documents (e.g., cleaning characterization/inactivation reports and acceptance limits reports)

• Coordinate with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure validation requirements are met

• Support site/network validation-driven continuous improvement initiatives

Requirements

• High school diploma/GED and 6 years of Manufacturing or Operations experience, OR Associate’s degree and 4 years of Manufacturing or Operations experience, OR Bachelor’s degree

• Technical writing and presentations skills

• Previous experience/proficiency using Kneat, CDOCs, Laboratory Inventory Management System, and Pi

• Sample management lifecycle experience

• Ability to gain expertise in equipment qualification and cleaning validation (validation strategies and procedures) for a biologics facility

• Ability to gain expertise reviewing/approving validation protocols and reports for commissioning, qualification, and change administration

• Involvement in technical implementation of validation tasks associated with cleaning validation, steaming validation (including autoclaves), and controlled temperature chambers (CTC)

• Demonstrated ability to read P&IDs

• Ability to gain expertise managing/owning multiple projects

Benefits

• Comprehensive employee benefits package including a Retirement and Savings Plan, group medical/dental/vision coverage, life and disability insurance, and flexible spending accounts

• Discretionary annual bonus program (or sales-based incentive plan for field sales representatives)

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible

• Career development opportunities