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The Facilities CAPA Engineer II plays a crucial role in ensuring compliance and continuous improvement within our pharmaceutical manufacturing operations. You will be responsible for investigating Engineering and Facilities departmental deviations, non-conformances, CAPAs, Standard Operating Procedure review/revisions, and facility issues related to pharmaceutical manufacturing processes, ensuring adherence to regulatory requirements and company standards. You will collaborate closely with cross-functional teams to identify root causes, implement and overseeing corrective and preventive actions (CAPAs) from initiation to closure, and drive continuous improvement for the facilities team.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• Non-conformance, Deviation, Investigation and CAPA point of contact for those items assigned to the Engineering and Facilities Team.

• Conduct thorough investigations into non-conformances and deviations that are assigned to the Engineering and Facilities Team identified during manufacturing, testing, or distribution processes.

• Perform root cause analysis to determine the underlying reasons for non-conformances and implement corrective and preventive actions (CAPA).

• Maintain accurate and detailed documentation and records of non-conformance investigations, including findings, root cause analysis, and corrective actions taken.

• Prepare and present reports on non-conformance trends, investigation outcomes, and effectiveness of corrective actions for management review during the weekly CAPA and CAPA Review Board meeting.

• Collaborate with cross-functional teams including Subject Matter Experts, Quality Assurance, Manufacturing and Supply Chain to resolve non-conformances promptly and effectively and to develop CAPAs.

• Review and perform revisions to Standard Operating Procedures as needed and/or when they are due for review.

• Generate Change Requests and performs Standard Operating Procedures revision in the Agile Electronic System.

• Identify opportunities for process improvements to prevent recurrence of non-conformances and enhance overall quality and efficiency.

• Ensure timely closure of investigations and CAPAs and maintain appropriate documentation according to regulatory requirements and company procedures.

• Participate in internal and external audits, providing investigation reports and supporting documentation as necessary.

• Monitor key performance indicators (KPIs) related to investigations and CAPAs and provide periodic reports to management.

• Support continuous improvement initiatives to enhance facility and manufacturing processes.

• Maintains organization of the Instrument and Equipment files and audits the quality of the calibration and maintenance documentation on a set frequency.

• Ensure all documentation meets Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) standards.

• Provide guidance and support to departmental CAPA owners throughout the process.

• Identify trends and recurring issues through CAPA data analysis.

• Assigned activities outside of routine activities as required.

• Secondary responsibilities are to support Project Engineering with capital project implementations.

• Utilizes the Computerized Maintenance Management System and manual file systems for investigations.

• Position is site based (on-site).

DESIRED MINIMUM QUALIFICATIONS

• Bachelor degree or equivalent with 3+ years of experience, Master degree with 2-5 years of experience.

• Must have Bachelor degree or higher in Engineering, or Biological Sciences discipline.

• Experience with CAPA and nonconforming product processes.

• Experience with process/test method/equipment validations.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

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