Validation Engineer, Senior

Forj Medical; Saint Paul (MN); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Health benefits

Dental and vision insurance

401K plans

Time off programs

Annual bonus program

Job summary

Forj Medical in Saint Paul, MN is seeking a Validation Engineer to own the site-wide equipment and process validation program. You will develop and implement the validation master plan and lead validation protocol execution to ensure manufacturing compliance and quality standards.

The ideal candidate must have a four-year degree in an engineering or scientific discipline and at least five years of experience in a regulated environment. This position offers a comprehensive rewards package including health benefits, 401K, and an annual bonus program.

Qualifications

• At least 5 years of experience in a cGMP or ISO-regulated environment.
• Proven ability to lead through clear communication and decision making.
• Experience effectively coaching team members and promoting accountability.

Responsibilities

• Develop and own the validation master plan and associated SOPs.
• Lead validation protocol development, execution, and reporting.
• Ensure equipment is evaluated for qualification applicability.

Skills

Leadership

Communication

Quality improvement tools

Critical thinking

Education

Four-year degree in engineering or a scientific discipline

Tools

Outlook

Word

PowerPoint

Excel

Visio

Job description

Job Summary

The Validation Engineer is the architect and primary owner of the site-wide equipment and process validation program. Reporting to the Director of Operations Quality, this individual operates with minimal direction to establish and sustain a robust validation function. They are responsible for developing the validation master plan (VMP), writing and executing validation protocols for equipment and processes, evaluating changes for impact to validation status, and training other engineering associates on validation concepts to strengthen integration of the validation program into the manufacturing organization.

Job Duties And Responsibilities

Validation Program Ownership

• Develop, implement, and own the VMP and associated standard operating procedures (SOPs).
• Drive the validation program to raise internal standards and exceed customer expectations, particularly for PCBA and cable component manufacturing.
• Apply prior experience, critical thinking, and sound judgment to prioritize new validation-related projects and identify system-wide improvements.
• Perform rigorous analysis of processes and trends to keep executive management informed of key metrics and to recommend improvements.

Technical Execution

• Lead validation protocol development, training, execution, closure, and reporting (IQ/OQ/PQ).
• Maintain a validation approach that effectively verifies manufacturing processes are robust and repeatable, with appropriate controls in place.
• Ensure that equipment is evaluated for applicability of qualification and that functionality is challenged appropriately when required.
• Serve as a subject matter expert (SME) for change management, identifying triggers to validate for new and existing equipment and processes and conducting detailed risk assessments.
• Document all plans and results as defensible supporting evidence for customers and regulatory interested parties.

Leadership & Mentorship

• Promote a culture of accountability by example and through coaching, mentoring, and upskilling.
• Effectively manage up and cross-functionally to drive team engagement.
• Develop strong and collaborative customer relationships.
• Act as the site SME by training staff on validation principles and new SOPs.

Requirements

• Four-year degree in an engineering, a technical, or a scientific discipline
• At least 5 years of experience in a cGMP or an ISO-regulated environment, including validation experience
• Experience navigating a business environment that is undergoing rapid change (e.g., startup, acquisition)
• Proven ability to lead through clear communication, critical thinking, and confident decision making
• Experience effectively coaching less experienced team members, including upskilling through training and mentoring and promoting a culture of accountability by example
• Demonstrated capability to manage relationships, including by managing up, developing customer relationships, and driving team engagement
• Proficiency in quality improvement tools and techniques
• Proficiency with standard business tools (e.g., Outlook, Word, PowerPoint, Excel, Visio)

Preferred Qualifications

• Experience with ISO 13485 and/or 21 CFR 820
• Experience managing direct reports

Working Conditions

• On-site office and manufacturing environment

EEO Statement

Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Employment Requirement

Must be authorized to work in the United States.

Compensation And Total Rewards Package

The salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.