Careers

Join VALIDATIONSTAR

Why Consultants Choose Us

• Access to top-tier life-science and IT opportunities

• Competitive pay rates

• Long-term contracts

• Career development guidance

• Exposure to leading global companies

Current Job Openings

Job Title: Controls & Automation Engineer

Location: United States

Job Summary:

• Support and execute automation, controls, commissioning, qualification, and validation activities for manufacturing equipment, packaging systems, process equipment, facility utilities, and OT systems in GMP-regulated pharmaceutical environments.

• Provide technical support for PLC, HMI, SCADA, historian, and industrial control systems to ensure reliable, compliant, and efficient manufacturing operations.

• Troubleshoot and maintain Allen-Bradley ControlLogix, CompactLogix, Siemens PLCs, FactoryTalk View, PanelView HMIs, SCADA platforms, industrial networks, and field instrumentation.

• Support facility utility systems including WFI, Pure Steam, HVAC, sterilization systems, clean utilities, process skids, and associated automation controls.

• Develop, review, and execute commissioning, qualification, and validation documentation including URS, FRS, Design Specifications, Risk Assessments, IQ, OQ, PQ protocols, FAT, SAT, traceability matrices, and SOPs.

• Perform PLC/HMI programming, modifications, troubleshooting, I/O verification, communication diagnostics, alarm management, and control system improvements.

• Support SCADA, OSI PI, PI Vision, Ignition, historian systems, and data review activities including trend analysis, alarm review, event monitoring, and data integrity verification.

• Investigate automation-related deviations, equipment failures, utility excursions, alarm events, and process interruptions while supporting CAPA implementation and root cause analysis.

• Participate in equipment installations, startup, commissioning, system upgrades, automation modernization projects, and continuous improvement initiatives.

• Review P&IDs, wiring diagrams, control panel drawings, instrumentation documentation, and automation system designs to ensure compliance with project requirements.

• Collaborate with Manufacturing, Maintenance, Engineering, Validation, QA, IT/OT, and external vendors to support production operations and maintain systems in a qualified state.

• Support change controls, periodic reviews, requalification activities, audit readiness efforts, and regulatory inspections.

• Provide technical guidance and training to maintenance technicians, operators, and engineering personnel on automation systems, troubleshooting, and GMP documentation practices.

• Ensure all automation and controls activities are performed in accordance with cGMP, FDA 21 CFR Part 11, ISPE GAMP 5, ALCOA+ Data Integrity principles, site procedures, and engineering standards.

Qualifications:

• Bachelor’s degree in Electrical Engineering, Automation Engineering, Computer Engineering, Mechanical Engineering, or related technical discipline.

• Experience supporting automation and control systems within pharmaceutical, biotechnology, medical device, or other GMP-regulated manufacturing environments.

• Strong knowledge of Allen-Bradley PLC platforms including ControlLogix, CompactLogix, Studio 5000, FactoryTalk View, PanelView, and RSLinx.

• Experience with Siemens PLCs, TIA Portal, SCADA systems, HMI applications, industrial networking, and process control systems.

• Hands-on experience with commissioning, qualification, validation, FAT, SAT, IQ, OQ, and PQ activities.

• Experience with OSI PI, PI Vision, Ignition, historians, alarm management, trend analysis, and data review systems.

• Understanding of FDA 21 CFR Part 11, GAMP 5, Data Integrity (ALCOA+), change control, deviations, CAPA, and validation lifecycle requirements.

• Experience reviewing P&IDs, electrical drawings, instrumentation documents, and control system specifications.

• Strong troubleshooting, analytical, documentation, communication, and problem-solving skills.

• Ability to work independently and collaboratively in a cross-functional GMP environment while supporting multiple projects and manufacturing priorities.

Job Title: Validation Engineer (CQV) 

Location: United States / Canada 

Job Summary:

• Support the commissioning, qualification, and validation of equipment, utilities, and facilities.

• Write and review URS (User Requirements), FDS (Functional Specs), and validation quality strategy.

• Execute IQ, OQ, PQ protocols and summarize results in final reports. 

• Perform risk assessments (e.g., FMEA), change control impact assessments. 

• Support FAT / SAT testing, collaborate with vendors during these phases.

• Handle deviations, CAPAs, and investigation related to CQV activities. 

• Maintain compliance with regulatory requirements (cGMP, 21 CFR Part 11, etc.).

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related discipline. 

• 3–8 years of experience in pharmaceutical / biotech validation. 

• Practical experience with IQ, OQ, PQ validation. 

• Strong documentation and report-writing skills. 

• Knowledge of utility systems (e.g., WFI, clean steam), process control, automation, calibration. 

• Familiarity with quality systems and audits.

Job Title: Senior CQV Engineer / Validation Engineer (Consulting / Contractor)

Location: United States / Canada

Job Summary:

• Serve as a validation subject matter expert for CQV activities (IQ, OQ, PQ) across client projects. 

• Lead or contribute to the creation, review, and execution of validation documentation (qualification protocols, reports, test plans). 

• Mentor junior validation engineers in best practices of CQV. 

• Engage in FAT (Factory Acceptance Testing), SAT, and other commissioning phases.

• Collaborate with cross-functional teams: vendors, operations, quality, automation.

• Plan and track CQV activities, resolve issues, close punch items, non-conformances, and deviations. 

• Participate in risk assessments, root cause analyses, and regulatory inspections / audits. 

Qualifications:

• Bachelor’s or Master’s degree in Engineering, Science, or a related field. 

• Minimum ~5 years of validation / commissioning experience in pharma / biotech.

• Good understanding of GMP and validation standards. 

• Strong documentation skills and validation protocol expertise. 

• Experience with risk-based validation (ASTM E2500). 

• Excellent communication, problem solving, and project coordination capabilities.

Job Title: Automation Engineer

Location: United States 

Job Summary

• Design, develop, and maintain automation systems used in pharmaceutical manufacturing and laboratory environments

• Support automated production equipment, control systems, and process instrumentation to ensure consistent product quality

• Work with cross-functional teams (engineering, validation, quality, and production) to improve manufacturing efficiency and compliance

• Ensure automation systems comply with regulatory standards such as GMP (Good Manufacturing Practice) and FDA guidelines

• Troubleshoot and resolve automation and control system issues to minimize downtime and production delays

• Support validation activities for automated systems, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)

• Implement improvements to increase reliability, safety, and efficiency of manufacturing processes

Qualifications:

• Bachelor’s degree in Electrical Engineering, Automation Engineering, Chemical Engineering, or related field

• Experience in pharmaceutical, biotech, or regulated manufacturing environment

• Knowledge of PLC systems, SCADA systems, and industrial control systems

• Familiarity with GMP, FDA regulations, and validation documentation requirements

• Strong understanding of process automation and instrumentation

• Ability to troubleshoot hardware and software control systems

CSV Engineer

Location: USA

Job Summary

• Support and execute Computer System Validation (CSV) activities for computerized systems used in pharmaceutical manufacturing, quality, and laboratory environments

• Ensure computerized systems comply with regulatory requirements such as GMP, FDA 21 CFR Part 11, and EU Annex 11

• Develop and maintain validation documentation including Validation Plans, Risk Assessments, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices

• Collaborate with IT, QA, engineering, and vendors to validate automation systems, control systems, and software applications

• Perform system testing and verification to ensure data integrity, security, and system reliability

• Support audits and inspections by providing CSV documentation and compliance evidence

• Manage system lifecycle activities including change control, periodic review, and re-validation

Qualifications:

• Bachelor’s degree in Computer Science, Engineering, Information Technology, or related field

• Experience in pharmaceutical or regulated life sciences environment

• Strong understanding of Computer System Validation (CSV) principles and GxP regulations

• Knowledge of FDA 21 CFR Part 11, data integrity (ALCOA+), and electronic records/electronic signatures

• Experience preparing and executing validation documents (URS, IQ, OQ, PQ, risk assessments)

• Familiarity with change control, deviation management, and CAPA processes

• Strong documentation, analytical, and problem-solving skills

Apply Now

Email your resume to jayaben@validationstar.com