PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT.

• Delivers Quality ownership of the facilities and equipment (critical systems) and associated processes, as well as the quality processes that govern them.
• Drives engineering change control (ECR) for critical equipment and controlled areas which include the timely preapproval and post approval of change controls.
• Performs impact assessments for Critical Systems requested for presentation to Change Control Review Board (CCRB).
• Provides support to the plant during operational run times as well as during maintenance shutdown activities both of which include off shift coverage.
• Provides quality oversight for software validation, equipment qualification, and facility commissioning and validation. Reviews, and approves validation documentation for critical systems and equipment.
• Troubleshoots problems related to critical systems and equipment (Water, HVAC, Pest Control, etc). Analyzes data and implements both corrective and preventative actions to enhance processes.
• Works with Engineering & Maintenance to identify possible trends in FMS and review impact.
• Participates as the main point of contact and driver in quality projects and teams to implement improvements to the facilities and equipment quality system infrastructure to meet regulatory requirements. Proactively taking ownership of quality processes and implementing solutions in support of continuous improvement.
• Reviews, and approves investigations related to critical systems and equipment. Analyzes data, conducts root cause investigations, performs gap analyses and risk assessments, develops corrective or preventive actions, and implements procedural and physical changes to reduce defects, improve efficiencies, and ensure compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
• Reviews and approves quality documentation such as deviation, OOT, OOS and complaint investigations, ensuring adequate root cause analysis as well as identification and implementation of corrective and preventative actions (CAPA).
• Reviews and approves quality documentation such as master batch records, specifications, SOPs, and other associated documentation. Analyzes system and document changes for appropriateness and ensures adequate impact analysis.
• Reviews and approves weekly system releases.
• Maintain critical system quality attributes metrics to drive the process of continuous improvement
• Provides training to appropriate personnel related to facilities and equipment quality system to build quality awareness and may mentor other Quality Engineers.
• Interacts with Regulatory Officials to convey the compliance level of Critical Systems during inspections.

REQUIREMENTS

• Bachelors in technical science, engineering, information systems or related field
• Minimum 5 - 8 years manufacturing experience with emphasis in Pharmaceutical industry
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
• Must have technical quality systems knowledge, qualification and validation practices
• Working knowledge of aseptic processing is highly preferred
• Working knowledge of cGMP practices to include 21 CFR Part 210, 211 and Part 11, Electronic Records, USP, ISO 13485 and 14644, and ISPE trends and guidelines
• Must be proactive, have experience with high performance teams, strong interpersonal, leadership and project management skills
• Computer expertise in application programs such as word processing, spreadsheets, relational databases, project management and power point
• Must be able to interact with varying levels within the company
• Skilled in the application of continuous process improvement tools (e.g. six sigma, lean manufacturing, DMAIC) is preferred
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results
• Must have good technical written and verbal communication skills, good documentation skills, good organizational skills and good interpersonal skills
• CQE or Black Belt certification a plus.
• Experience with Trackwise and Documentum preferred
• Travel 10-20% as needed

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.