Senior Validation Engineer

The Process Engineer will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives. Responsible for execution of maintenance and calibration activities and commissioning activities for projects at site level. Execute for design, execution and hand-over projects within cost, time schedule, quality and functionality within technical area of responsibility. Flexible to support second shift when needed to ensure the project's critical timeline is maintained.

Major Accountability:

Guide and supervise onsite installation and commissioning activities of equipment/system

Install subsystems owned by *** in production line

Implement equipment optimizations and modifications

Participate on the assessment or implementation of special projects or initiatives with cross-functional teams.

Lead complex root cause investigations

Performs change assessments

Preparing, scheduling, coordinating, and monitoring of assigned engineering projects.

Reviews equipment and engineering systems to support root cause analysis investigations and trend investigations.

Second line escalation in case of equipment failures

Driving continuous improvement from an asset perspective

Reducing safety risks through simplification and error proofing machines

Improving equipment reliability through equipment design modifications

Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI).

Set-up maintenance for new equipment (incl. spare part needs).

Assist with preparation of plans for maintenance / calibration / qualifications.

Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request.

Assist with preparation of estimates for bids and proposals.

Act as SME to review/approve DQ, IQ, OQ and PQ protocols and reports.

Perform GMP risk assessments (incl. Sensors SRA).

Independently manage and resolve deviations on equipment and systems.

Support internal and external audits.

Provide technical trouble shooting during Startup, PQ and validation activities

Develop periodic requalification plan

Execute periodic requalification plan

Utilize automation (Scada / PLC's / Control Networks hardware) for data gathering and equipment optimization opportunities

Assist in troubleshooting of process / plant equipment including isolator, filling line and utilities.

Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed.

Write/revise accurate engineering documents for various production system.

Supply information and technical data for securing spare parts.

Provide responsive customer support with emphasis on customer satisfaction.

Perform startup and commissioning activities as required.

Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs

Complete and provide accurate documentation, as required in cGMP operations.

Use of CMMS system for documentation of relevant work.

Other related duties as assigned.

Minimum Requirements:

Bachelor’s Degree in Engineering or related field is required

5+ years of relevant experience in a GMP environment is required

Previous experience in the pharmaceutical industry is required.

Pharmaceutical aseptic filling experience is preferred

Vendor management experience is a plus

Knowledge/experience in automation or computer system validation (CSV) is a plus

Experience managing projects is preferred