Validation Engineer II

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. 

For more information, please visit www.resilience.com

Position Summary & Responsibilities

Performs, leads and troubleshoots the qualification of facility, utility, process, and cleaning, validation. Specializing in general validation support. Maintain adherence to the Validation Schedule for requalification activities to ensure continued compliance. Support Validation activities throughout the site including field work and document drafts.

Responsibilities:

• Author, Review and approve documentation needed for qualification of equipment and processes.
• Prepare documentation of activities, actions, and/or results.
• Monitor records to ensure compliance with regulatory requirements.
• Complete required training.
• Ensure proper documentation practices during job activities.
• Answer compliance and process questions from others.
• Communicate policies and procedures to employees.
• Gather, organize, and communicate operational information to others.
• Communicate priorities and progress to team on a continuing basis.
• Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
• Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions.
• Initiate appropriate action when process deviations occur.
• Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
• Coordinate with representatives from other departments.
• Interact with other departments to ensure that product is inspected under validated conditions.
• Interact with other departments to implement corrective/preventative actions.
• Participate in cross-functional teams to meet strategic goals.
• Review and approve OCMs, change controls, and document revisions.
• Attend team meetings to discuss progress, initiatives, and/or other matters.
• Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs and so on.
• Read and interpret diagrams, drawings, and other schematics.
• Facilitate the execution of validation protocols for processes, equipment, packaging, and/or cleaning.
• Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.
• Coordinate qualification activities.
• Create new process medications.
• Participate in troubleshooting activities.
• Lead process improvement activities and teams to meet strategic goals.
• Facilitate communication between management and non-management.
• Investigate deviations.
• Close out deviations, CAPAs, and/or pAFCAs as needed.
• Identify temporary and permanent fixes to address issues.
• Interact with regulatory agency personnel during audits and inspections.
• Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
• Participate in new equipment design specification.
• Read technical publications and manuals and write associated procedures.
• Approve new and updated SOPs.
• Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.
• Occasionally Provide "off shift" support (for example: night shift support if you normally work day shift).
• Assist process engineering and managers with improvement projects.
• Recommend compliance resolutions to management.
• Review and approve requirements, specifications, drawings, coding procedures, and guidelines.

Minimum Qualifications

• Experience in validation or process engineering.
• Demonstrated experience in a manufacturing or processing setting
• Ability to expertly read and interpret drawings and diagrams
• Strong analytical skills, with keen attention to detail
• Strong communication skills, both written and verbal
• Demonstrated knowledge of health and safety guidelines
• Good report writing skills
• Good problem-solving abilities
• Ability to prioritize own time and workload

Preferred Qualifications

• Bachelor’s degree in engineering, Computer Science, or a related discipline