The Validation Engineer is critical to ensure that manufacturing, packaging and utilities equipment is maintained in a state of compliance. Authors and executes Installation and Operational Qualification Protocols to ensure equipment is properly qualified and suitable for use.
- Author and execute Installation and Operational Qualification (IQ/OQ) protocols and reports for pharmaceutical manufacturing, packaging equipment and utilities equipment.
- Assist in the design and procurement of new process and utility equipment and lead installation, start-up and commissioning or qualification activities.
- Author IQ/OQ protocols for new or used equipment purchased
- Review IQ/OQ protocols provided by equipment manufacturers to ensure compliance with site procedures.
- Coordinate with manufacturing department to complete re-qualification activities with minimal impact to production schedule.
- Write/revise Standard Operating Procedures (SOPs), protocols and maintenance reports for manufacturing and utility equipment.
- Initiate Change Controls for Engineering Department activities and ensure their timely closure.
- Process improvement activities; including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT.
- Design and execute studies as required to investigate, optimize, troubleshoot, and implement process improvements.
- Assist Engineering staff to troubleshoot equipment or facility problems and report them to supervisor.
- Read and interpret equipment manuals, schematics and work orders to perform required maintenance and service.
- Assist with maintenance compliance duties.
- Assist the supervisor in compiling SITE MASTER PLAN and other relevant documents associated with inspection readiness
- All other job-related duties.
Specialized Skills and Knowledge:
- Bachelor's Degree in Engineering or related discipline
- 3+ years' experience authoring and executing Equipment QualificationProtocols in the Pharmaceutical industry.
- Experience with Computer Systems Validation/21 CFR Part 11
- Proficient in Microsoft Office Suite (Word, Excel, Outlook)
- Strong interpersonal communications skilled with excellent technical writing abilities
- Demonstrated application of Good Engineering Practices on projects
- Possess in-depth knowledge of GMP and regulations
1. Analytical Thinking/Problem Solving
2. Collaboration/Team Work
3. Multitasking/Good Communication Skills