Position: Validation Engineer (Level I, II and Sr)

Office Location: USA (North Carolina) ONSITE POSITION

PACIV, a global leader in industrial automation solutions with offices in Puerto Rico, United States, and Ireland, and servicing the Life Sciences, F&B, WTP/WWTP and Utilities industries is looking for a full-time employed Validation Engineer based out of our USA office (North Carolina).

Job Description:

The Validation Engineer role pertains to Commissioning and Qualification activities being managed onsite at our client’s facilities in North Carolina (Raleigh/Durham and Charlotte). These C&Q activities involve the Verification of new processes and systems which support production facilities in an FDA-regulated and GMP-governed Pharmaceutical manufacturing environment. These systems include the following:

• Automated Asset Delivery Systems and Applications (i.e. Dry and Wet/API assembly, Visual Inspection Systems, etc.)
• Packaging Systems and Applications (i.e. Palletizer, Cartoners, Labelers, etc.)
• Utility Systems and Applications (i.e. Clean Steam, Parts Washers, Autoclaves, etc.)

This role will be integrated with our new business objective and team, PACIV-NC (North Carolina), which is being developed and assembled to support multiple clients in the ever-emerging Life Sciences and Biotechnology sectors in RTP. The primary objective of the PACIV-NC team will be supporting our client’s commercial facilities that manufacture multiple commercial and clinical bulk drug substances by providing seamless Validation support and expertise to Quality and Manufacturing operations and their respective groups.

Job Responsibilities

• Become familiar with the site Quality and Manufacturing procedures.
• Complete client-assigned training curriculum and maintain training at 100%
• Draft and update C&Q related deliverables
• Track and bring to closure C&Q related action items
• Provide guidelines and educate business partners on the appropriate application of Validation and Verification practices
• Review and/or approve documents as outlined in the C&Q Plan
• Monitor C&Q process metrics for the project
• Identify potential process changes for Continuous Improvement
• Support Design Review sessions (to be led by team Client’s Tech Lead)
• Act as liaison to other project functions and maintain alignment across team members
  • Includes working with Client OEMs and CMs, which will include correspondence and oversight of their C&Q process
• Understand concepts and processes involved to design and deliver GMP equipment
• Provide monthly roll-up outlining current month accomplishments, next month plans, scope changes, financials (baseline, forecast, actual, and project budget), staffing plan (baseline, forecast, and actual) and issues/risks.

Requirements

• Bachelor of Science degree in Engineering or Comparable Technical field
• Minimum of three (3) years Commissioning, Qualification, and/or Validation experience within technical/regulated industries
• Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. This includes deliverables such as Planning (Project Validation Plan or Validation Master Plan), User/Functional Requirements, Design Specifications, Design Qualification (DQ), Commissioning (FAT, SAT, Startup), Qualification Test Protocols (IQ/OQ/PQ), Process Validation (PV), Final Reporting, and support documentation (i.e. Traceability Matrices, SOP development, PMs, calibration, etc.)
• Knowledge of industry CSV and C&Q expectations and requirements (e.g. FDA guidelines, USP, GAMP 5, ISO, etc.)
• Excellent critical thinking and problem-solving skills
• Ability to prioritize a wide range of workload with concurrent critical deadlines
• Desire to grow professionally with PACIV-NC project team and through ongoing training opportunities

Preferred Qualifications:

• Knowledge and experience with cloud-based document approval, execution, and retention system, specifically eCQ KNEAT
• Works well with others, within a team and takes accountability
• Can handle a high-pressure, high-stress work environment
• Result driven and self-motivated
• Strong interpersonal and communication skills (verbal and presentation)
• Organized, with strong computer literacy such as MS Project, Excel, etc.

Other Requirements

• Location: North Carolina ONSITE
• Standard Day Shift (~ 8 am – 5 pm or similar is expected)
• Travel: Up to 15% for the following:

• Onsite FAT and SAT execution supporting OEM and CM locations (may be Domestic-based or International Travel)
• Various trainings, conferences or meetings with vendors, suppliers, etc.

Compensation

Competitive Salary and Benefits Package, which includes:

• Paid Time Off (PTO) for vacation, sick, and company holidays

• PTO is earned on an accrual basis throughout the calendar year

• Health Insurance

• PACIV pays 90% of the premium for the health insurance plan. Monthly contributions made by PACIV and are distributed through an HSA (Health Savings Account)

• $25,000 Basic Life Insurance Plan for all full-time employees, with additional plan options offered at the employee’s cost
• 401(k) Retirement Plan with company match
• Project Performance Bonuses (for qualified projects and employees)