Allergan Aesthetics, an AbbVie Company · 2 months ago
Senior Engineer, Validation Commissioning (onsite role in MA)
Worcester, MA
Full-time
Onsite
Mid, Senior Level
$82K/yr - $158K/yr
6+ years expAbbVie is a global company focused on discovering and delivering innovative medicines and solutions. The Senior Engineer, Validation Commissioning will work with project teams to ensure the commissioning, qualification, and validation of new and modified equipment and processes, ensuring compliance with regulatory standards and risk management.
BeautyManufacturingPharmaceuticalWellness
Responsibilities
Work with end-user and project engineer to develop User Requirements Specifications and Functional / Design Specifications for new or modified equipment, facilities, and utilities
Support Factory Acceptance Testing in conjunction with Project Engineer to confirm unit is acceptable
Identify risk controls, critical elements and traceability of equipment design based on FMEA or other risk assessment
Develop and execute commissioning, qualification and validation test protocols to ensure that the unit functions according to specifications
Perform minor troubleshooting of issues encountered during commissioning and documentation of unresolved issues
Able to support broader aspects of projects at times including: project leadership, developing operational procedures, support training of maintenance/technical staff/operators on new equipment, reviewing new or modified product documentation to ensure compatibility with qualified equipment and implementing changes in equipment parameters or recipes
Leads Execution of Risk Management including, periodic review and update per the Validation Master Plan, interface with best practices, establishing team's work practices including overall program, ccRA. Understands risk management principles. Can find and review documentation. Understands controls, impact of change, trace controls, and can estimate ratings using appropriate scale. Timely. Demonstrated success in FMEA authorization/facilitation
Qualification as QRM facilitator commensurate with responsibility
May supervise contract validation resources in the timely completion of activities in his/her area of responsibility
Qualification
Required
Bachelor's Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3+ years of significant engineering and/or operational experience
Experience in the development of commissioning, qualification, validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny
6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment
Ability to manage complex projects and multiple projects (5+) simultaneously
Preferred
A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries
Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing
Ability to supervise junior or contract team members (prior supervisory experience preferred)
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
Company
Allergan Aesthetics, an AbbVie Company
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products.
1001-5000 employees
H1B Sponsorship
Allergan Aesthetics, an AbbVie Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (16)
2021 (14)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Nicole Mowad-Nassar
Senior Vice President, AbbVie and President, Global Allergan Aesthetics
Recent News
2025-12-04
Company data provided by crunchbase