Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

What You Will Achieve

The Sr Automation Compliance Engineer will have overall responsibility for managing regulatory aspects of the process automation and control systems used in the manufacture of sterile injectable. This position will provide engineering and technical support related to the operation, maintenance, installation, startup/commissioning, testing, and qualification of systems within a sterile injectable manufacturing facility.

How You Will Achieve It

• Facilitate and participate in the investigation teams created to determine root cause of exemption reports, QARs and laboratory investigation reports.

• Serve as a liaison between quality, Operations and regulatory/Compliance to facilitate timely closure of investigations and/or CAPAs.

• Promote safety within the workplace by following site safety procedures and perform proactive safety assessments, foster a safe work culture.

• Support the operation and troubleshooting of manufacturing equipment and control systems.

• Responsible for investigations and CAPAs related to site Automation system and instrumentation.

• Manage technical writing and document review.

• Support all investigations and audits (internal and external) as needed.

• Takes a tactical role on investigations and improvements partnering with operations, quality, supply, EH&S and other functions.

• Responsible for Periodic review of the Automation systems, user account reviews and procedures.

• Follows Good Documentation Practices per compliance requirements (i.e., 21 CFR Part 11, Data Integrity).

• Provides support and guidance to Automation and Maintenance Technicians in Good Documentation Practices.

• Ensure calibrations in compliance with site policies and procedure and assuring traceability to the National Institute of Standards and Technology (N.I.S.T.).

• Develop, review/update Calibration/Automation Job Aids/Procedures.

• Generate, review/approve (as SME) and update required Calibration documentation (i.e., instrument form).

• Provide off-shift and on call support when necessary.

• Generate, review/approve (as SME) and update Automated System Life Cycle documents.

• Responsible for implementation of compliance initiatives (i.e. Automation Change Control, Periodic reviews, Alarm Management, Compliance Metrics).

• Design and implementation support for minor functional and process changes, either smaller.

projects, remediation activities or capital projects.

• Support FAT/commissioning/qualification activities as required.

•Support future capital projects and assure site automation standards are followed.

• Assist other departments in evaluating historical process/equipment data.

• Provide automation guidance and training to other functional groups (i.e. Operations, Validation, Maintenance, etc.).

Qualifications

Must-Have

• Applicant must have HS Diploma with eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.

• Demonstrated experience in Automation Engineering experience with System Development Lifecycle (i.e. user requirements, system design specification, system impact assessment documents)

• Experience on Automation Compliance with strong knowledge of Computerized Systems Validation, Compliance regulations (i.e., 21 CFR Part 11, Data Integrity) and Automation standards (GAMP).

• Experience with Root Cause Failure Analysis, Equipment Criticality Ranking, PM/PdM optimization, and/or Failure Modes and Effects Analysis

• Understanding and experience with process automation systems and calibration.
• Strong knowledge and understanding of Current Good Manufacturing Practices {part of GxP}
• Excellent oral and written communication skills
• Excellent interpersonal effectiveness and communication skills (written and oral).

• Working knowledge of MS application (i.e. Excel, Word, Outlook, Teams, Power Point, Visio, Project, etc.)

Nice-to-Have

• Relevant pharmaceutical experience.

• Understanding of computer programming languages, cyber security, Network+.

PHYSICAL/MENTAL REQUIRE