Engineer I, Validation

Job Description

Job Summary: The Validation Engineer, a pivotal member of the Engineering Department, operates both independently and collaboratively to author and execute IQ/OQ/PQ protocols, engineering studies, and facility qualifications. Ensuring adherence to manufacturing specifications, Good Manufacturing Practices (GMP), and national standards, they undertake engineering projects and troubleshoot issues, fostering collaboration across departments for seamless operations.

Key Accountabilities:

Engineering Services:

Adhere to all company and cGMP procedures as well as applicable safety regulations.

Author change controls, SOPs and protocols.

Generates and executes validation protocols, and summarizes studies to ensure compliance with manufacturer and SPI specifications, with current Good Manufacturing Practices, and national standards

Responsible for confirming all communicated validation plans to applicable management

Provides technical assistance in the form of rationales or validation studies

Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment.

Troubleshoots and resolves issues as needed

Project Management:

Manage multiple projects with competing deadlines

Manage external resources to complete tasks outside SPI’s capabilities

Manage approvers of documents and procedures and ensure timely closure of tasks

Manage project-related Change Requests form initiation through closure, including presentation to Change Control Committee

Assist with deviation investigation and identify areas for CAPAs as needed based on root causes.

Source and procure equipment, supplies and other materials as needed.

Develop and maintain cross-functional relationships

Qualifications:

Education & Experience:

Bachelor of Science in Engineering or related field preferred.

Experience in pharmaceutical, medical device, or biotechnology industries, particularly in validation, QA, or R&D roles.

Knowledge:

Proficiency in FDA regulations, GMP/GLP/GCP, and Lean Manufacturing principles.

In-depth understanding of pharmaceutical plant operations.

Skills & Abilities:

Proficient in Microsoft Word, Excel, Power Point, Project, AutoCAD and other software relevant to the performance of the Job

Experience authoring change controls in Trackwise or other quality management system

Experience authoring SOPs in MasterControl or other document management system

Integrity – Works with integrity and ethically; Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Collaboration – Works well in group problem solving situations; Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions.

People – Treats people with respect; Keeps commitments; inspires the trust of others; Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; promotes a harassment-free environment.

Responsive – Identifies and adapts to priority issues as they arise; Communicates with management and team members effectively; Works quickly and efficiently

Proactive – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.

Organized – Tracks deadlines and adheres to schedules; Writes clearly and informatively; Presents numerical data effectively.

Learning Mindset – Adapts to unfamiliar situations as needed; Open to new ideas and methods; Readily familiarizes self with new equipment and processes

Physical Requirements:

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds

Climb ladders and work in high, precarious places up to elevations of 75 feet

Regularly exposed to work near moving mechanical parts

Exposed to wet or humid conditions

Exposed to outdoor weather conditions

Regularly exposed to high noise environments

Exposed to extremely dusty environments

Exposed to chemicals used in the manufacturing process