Validation Engineer III

Lensa; College Station (TX); Remote; USD 60,000 - 80,000; Full time

Job summary

An innovative firm is seeking a dedicated Automation Service Engineer to join their mission-driven team. This role involves generating and executing validation deliverables for critical systems within a fast-paced, state-of-the-art environment. Candidates should possess a strong background in validation processes within the pharmaceutical or biotechnology sectors, particularly in FDA-regulated settings. With a focus on collaboration and adherence to industry standards, this position offers the chance to contribute to groundbreaking advancements in medicine. If you're passionate about making a significant impact in healthcare, this opportunity is for you.

Qualifications

• Master’s or Bachelor’s with experience in Validation in FDA-regulated environments.
• Strong knowledge of engineering principles and FUSE Systems.

Responsibilities

• Generate and execute validation deliverables for FUSE systems.
• Plan validation activities and maintain status updates.

Skills

Validation in pharmaceutical industry

Engineering principles

Communication skills

Knowledge of FDA regulations

Microsoft Office proficiency

Education

Master's Degree

Bachelor's Degree

Associates Degree

Tools

FUSE Systems

Clean Utilities

Sterilization Equipment

Temperature Controlled Units

Microsoft Office

Job description

Becton Dickinson

Automation Service Engineer (Field-Based)

Remote

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.

Job Description

Reports to: Associate Director, Validation

Work Location: College Station, TX

Primary Responsibilities:

1. Generate, obtain approvals, and execute validation deliverables for FUSE systems and relevant infrastructure, including Validation Plans, System Impact Assessments, User Requirements Specification, Risk Assessments, Installation/Operational Qualifications and Performance Qualifications (as applicable) and Validation Final Reports, ensuring documents meet regulatory and procedural requirements.
2. Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work.
3. Review all FUSE System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
4. Review, and update SOPs, forms, templates, documentation, and files.
5. Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation and industry codes.
6. Perform other duties as assigned.

Qualifications:

1. Master’s Degree with 2+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environment, OR;
2. Bachelor’s Degree with 4+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
3. Associates Degree with 6+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.

Degree in Engineering or Science Discipline preferred.

Significant working knowledge of engineering principles.

Strong working knowledge and expertise in FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, Temperature Controlled Units (2-8 C, -80 C, LN2 Freezers, Incubators) among others.

Efficient Knowledge ISPE Baseline 5, Vol. 2 – Commissioning and Qualification and FDA industry regulations.

Solid written and oral communication skills.

Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).

Ability to work with general guidance from Sr. Validation Engineers-Specialists /Validation Manager.

Able to work in fast-paced, state of the art, alternately research and customized manufacturing facility.

Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

1. Experience prolonged standing, some bending, stooping and stretching.
2. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
3. The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.

Attendance is mandatory.

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.