Engineer II, Automation Validation

General Description:

Engages in the day-to-day activities of the Automation Validation and CSV function, ensuring the successful management of related activities and large projects. Supports Automation Validation and CSV objectives, whilst adhering to regulatory compliance and achieving commercial success. This is a site-based position supporting the facility and will require gowning into the manufacturing suites.

Ensures the Automation Validation and CSV function supports operational needs and ensures regulatory compliance requirements are met. Works to support Key Performance Indicators (KPIs) such as SOP mandated cycle times, on time closure dates, and objectives, whilst adhering to regulatory compliance and achieving business success. Creates and/or reviews SOPs needed to support the business. Works to support both internal GMP audits and Health Authority audits. Supports Automation Validation and CSV related tasks as assigned by Management.

Responsibilities

• Develop and approve cGMP documents including, but not limited to: Automation Qualification, Commissioning, Master Validation Plans, SOP’s, Comparability reports, Periodic Reviews, and Requalification.

• Lead validation activities for automated manufacturing systems, equipment, control systems, and computerized systems.

• Develop and maintain automated test scripts and frameworks where appropriate.

• Validate PLC, HMI, SCADA, DCS, EMS, vision systems, data acquisition systems, and related automation platforms.

• Evaluate automation and computerized systems for compliance with applicable GxP, data integrity, and electronic records requirements.

• Participate in system design reviews, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification, and production implementation.

• Perform risk-based assessments to identify critical process parameters, system functions, and validation requirements.

• Ensuring that the Validation department meets or improves key performance indicators (KPIs). Works to ensure all validation projects are on time and on budget. Ensures adequate validation resources. May manage validation consultants on a large project basis, as needed.

• Leading and Managing projects for the validation of equipment, processes, and products to meet all safety, quality, regulatory and operational requirements.

• Review of equipment specification/design/procurement/installation and validation.

• Project planning and execution including scheduling, task management, milestone planning and reporting.

• Generation, review, and approval of project documentation (User Requirement Specifications, validation protocols, reports) and Standard Operating Procedures.

• Employee will be required to work closely with both manufacturing, quality, and engineer associates.

• Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.

• Position flows based on project needs up to and including quality approvals.

• Undertaking any other duties for any department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.

Required Skills/Experience

• BS or higher in engineering and/or Scientific degree (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline).

• Strong knowledge of cGMP’s.

• Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.

• Biotech and/or Sterile manufacturing and aseptic processing knowledge required.

• Minimum of 4 years’ experience in validation (with Bachelors degree) or 3 years (with a Masters degree), biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.

• Knowledge of cGMP’s and Data Integrity principles.

• Demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Good personal leadership.

• Good communicator (written and verbal) at all levels.

• Customer focused. Strong analytical and problem-solving ability.

• Hands-on approach, with a ‘can do’ attitude. Able to work under minimal or appropriate supervision level.

• Ability to prioritize, demonstrating good time management skills.

• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.

• Self-motivated, with the ability to work proactively using own initiative.

• Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP desirable but not required.

Preferred Skills/Experience

• Knowledgeable in Computerized System Validation (CSV) and/or Automation Validation.

• Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP desirable but not required.

Physical Requirements :

• Ability to work in an office environment, construction site, and laboratory or manufacturing areas.

• May require up to 5% travel, including visits to partner or manufacturing sites.

• Must be able to sit, stand, and use standard office equipment for extended periods.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.