Position: Sr. Validation Engineer

Office Location: USA (Rhode Island) ONSITE POSITION

PACIV, a global leader in industrial automation solutions with offices in Puerto Rico, United States, and Ireland, and servicing the Life Sciences, Food and Beverage, Water/Wastewater and Utilities industries is looking for a full-time employed Senior Validation Engineer based at our USA office (Rhode Island).

Job Description:

The Senior Validation Engineer will support standard Validation Engineering activities being managed onsite at our client’s facilities in Rhode Island. These C&Q and CSV activities include equipment and systems which support production facilities in an FDA-regulated and GMP-governed pharmaceutical product manufacturing environment.

This role will be integrated with our existing Outsourcing Services Provider (OSP) business model for the Client, which is comprised of a team of PACIV associates executing and maintaining various Validation and Automation tasks and business functions. PACIV’s OSP team is responsible for supporting the client’s commercial facility that manufactures multiple commercial and clinical bulk drug substances by providing seamless support to Quality and Manufacturing operations and their respective groups).

In addition to the following job responsibilities, the Senior Validation Engineer will also serve as PACIV’s Validation Site Lead and will oversee all Validation activities executed by fellow PACIV Validation associates.

Position Responsibilities and Essential Functions:

• Participate in Computer System Validation (CSV) project scoping and strategy for small projects, day-to-day support, and large capital projects. May include involvement in change control definition, risk assessment, validation master planning and other high-level aspects.
• Author and execute technical Computer System Validation (CSV) documentation for complex automated control systems and processes in accordance with client quality system standards, current Good Manufacturing Practices (cGMP) and Good Automated Manufacturing Practice (GAMP).
• Review executed documentation for Good Documentation Practices (GDP) and compliance to qualification and test protocols. Work with test executors to coach GDP and proper execution practices.
• Support CSV for pharmaceutical production systems (DeltaV DCS), utilities support (PLC/HMI/SCADA), and Building Management Systems (BMS).
• Contribute to the change control process by authoring and revising steps within the change control record management system.
• Serve as CSV subject matter expert by providing guidelines and educating business partners on the appropriate application of CSV practices and principles.
• Work directly with client Digital, Technology, and Innovation (DTI) group and Facilities and Engineering (F&E) Automation group resources to plan daily, weekly, monthly validation activities.
• Prepare, submit, and present weekly reports for CSV projects and activities. Monitor and report on project budget and financials monthly for all assigned projects.
• Complete client-assigned training curriculum and maintain training at 100%

Requirements:

• Bachelor of Science degree in Engineering or Comparable Technical field
• Minimum of eight (8) years of 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.)

Preferred Qualifications:

• Must be able to drive assignments to completion and collaborate with cross functional teams to drive decisions to support documentation completion.
• Knowledge of industry CSV and C&Q expectations and requirements (e.g., cGMP, FDA guidelines, USP, GAMP 5, ISO, etc.)
• Understanding and experience with automation technologies (DeltaV DCS, Rockwell Automation PLC and SCADA systems, Andover Controls, Siemens Building Technologies, and Johnson Controls).
• Works well with others, within a team and takes accountability
• Can handle a high-pressure, high-stress work environment
• Experience in a highly regulated and/or pharmaceutical environment is preferred.
• Result driven and self-motivated
• Strong interpersonal and communication skills (verbal and presentation)
• Organized, with strong computer literacy such as MS Project, MS Excel, etc.
• Desire to grow professionally with PACIV-RI project team and through ongoing training opportunities

Other Requirements:

• Location: West Greenwich, Rhode Island
• Standard day shift (8a-5p or similar is expected)
• Overtime is not expected on a routine basis, but occasionally required for critical project delivery
• Travel: 10% or less for training, 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)