Validation Engineer

Regular
16 Elkins, East Brunswick
Posted 2 months ago

Job Summary:

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.

Reporting Relationships                                                                                  

  • Individual Contributor

Essential Functions:

  • Author and execute Installation and Operational Qualification (IQ/OQ) protocols and reports for pharmaceutical manufacturing, packaging equipment and utility 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 the manufacturing department to complete re-qualification activities with minimal impact to the 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 Qualification [GG1] Protocols in the Pharmaceutical industry.
  • Experience with Computer Systems Validation/21 CFR Part 11 [GG2]
  • Proficient in Microsoft Office Suite (Word, Excel, Outlook)
  • Strong interpersonal communications skills with excellent technical writing abilities
  • Demonstrated application of Good Engineering Practices on projects
  • Possess in-depth knowledge of GMP and regulations

Key Competencies: 

1. Analytical Thinking/Problem Solving

2. Collaboration/Team Work

3. Multitasking/Good Communication Skills

Physical Demands/Factors:

While performing the duties of this job, the employee is regularly required to stand.  The employee is frequently required to walk; sit; use hands; talk; and hear.  The employee is frequently required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 kg (55 lbs).  Specific vision abilities required by this job include close vision, distance vision, and color vision.

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.

Avet is proud to be an Equal Opportunity Employer.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs

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