Job DescriptionAn engineering professional that works with project owners, automation engineers, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified automated systems equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The primary objective is to design and execute robust evaluation, testing, and documentation strategies that support risk management, commissioning, and validation in alignment with product, regulatory, and quality requirements. The role also contributes to optimizing automated systems, process controls, and related technical workflows that support reliable and compliant manufacturing operations
Responsibilities
- Work with end-user and project engineer, automation engineers, and system owners to develop User Requirements Specifications and Functional / Design Specifications for new or modified equipment, facilities, and utilities.
- Support Factory Acceptance Testing and related system verification activities to confirm equipment and automation solutions meet defined requirements before site deployment.
- 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 for equipment, utilities, and automated or computer-controlled systems to ensure performance against specifications.
- Perform minor troubleshooting of issues encountered during commissioning including control logic, integration, instrumentation, recipe/parameter settings, and documentation of unresolved issues.
- May support aspects of projects at times such as: 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.
- Supports Execution of Risk Management including, periodic review and update per the Validation Master Plan, interface with best practices, 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. May perform FMEA authorization/facilitation.
- May have Qualification as QRM facilitator commensurate with responsibility.
- Works with contract validation resources as part of a team in the timely completion of activities in his/her area of responsibility
Qualifications- Bachelor's Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 1+ years of significant engineering and/or operational experience
- Experience in the development of commissioning, qualification, validation or risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
- Experience with Computer System Validation (CSV) is required.
- 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
- Experience working with automation systems, controls, PLC/SCADA, instrumentation, or computer-based process controls strongly preferred.
- A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
- Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
- Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
- Works with junior or contract team members as part of a team
- Ability to manage multiple projects (3+) simultaneously
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolutediscretion, consistent with applicable law.
