Lead Investigators (Manufacturing/Quality Specialist — Sterile & Non-Sterile Operations)

Principal Objective

Provide operational scientific and compliance support to Sterile and Non-Sterile Manufacturing. Own and execute manufacturing investigations (QE NTR NOE) CAPA procedure development/revision and process-validation documentation. Adhere to all Security Environmental Health & Safety (EHS) and current Good Manufacturing Practices (cGMP) requirements.

Major Duties & Responsibilities

1. Investigations & CAPA: Ensure all QE NTR NOE and CAPA are investigated documented and closed on time applying effective root-cause and recurrence-prevention tools.

2. Regulatory Support: Review and provide input to regulatory submissions within area of responsibility.

3. Trending: Lead investigation/CAPA trend evaluations and drive systemic improvements.

4. New Product Introduction (NPI): Participate in NPIs to define documentation materials training and equipment modifications.

5. Process Monitoring: Help establish process parameters and control limits; support statistical monitoring.

6. Deviation Assessment: Support assessment of deviations and process-monitoring data.

7. Optimization: Monitor ongoing processes to improve cycle time productivity equipment performance yields and quality.

8. Technical Support: Recommend and implement process/equipment modifications; contribute to cost-reduction projects while ensuring cGMP compliance.

9. Documentation: Write evaluate and revise manufacturing documentation (e.g. SOPs MBRs); assist with training on scientific/technical process aspects.

10. Validation: Assist in generating and executing validation protocols and reports (sterile and non-sterile).

11. Inspections: Participate in regulatory inspections as needed.

12. Troubleshooting: Partner with area leadership to resolve process/equipment issues affecting yield cycle time quality or productivity.

13. Continuous Improvement: Provide alternatives and recommendations to maximize process and equipment performance.

14. EHS & Compliance: Contribute to Environmental Regulatory/Compliance permits and Process Safety Hazard evaluations.

15. Culture & Teamwork: Model the companys Core Behaviors; facilitate collaboration across functions.

16. Site Initiatives: Support site initiatives and perform other duties based on business needs.

Minimum Qualifications

• Bachelors degree in Engineering Life Sciences or related discipline.

• Demonstrated experience in pharmaceutical manufacturing (sterile and/or non-sterile).

• Hands-on ownership of QE/NTR/NOE CAPA and process validation documentation under cGMP.

• Strong technical writing and documentation skills (English; Spanish a plus).

• Proficiency with MS Office and familiarity with eQMS/EDMS tools for deviations CAPA and document control.

• Proven ability to collaborate cross-functionally (Manufacturing Quality Engineering EHS).

Preferred Qualifications

• Experience supporting regulatory submissions and regulatory inspections.

• Background in process monitoring/CPK trend analysis and risk assessment (e.g. 5-Why Fishbone FMEA/pFMEA).

• Exposure to NPI in GMP environments and to equipment/process troubleshooting.

• Experience training operators/technicians on SOPs MBRs or validation practices.

Work Environment & Compliance

• On-site role in a GMP-regulated facility.

• Must follow Security EHS and cGMP practices at all times and maintain inspection-ready documentation.