The Role
Support regulated biotech/pharma manufacturing by applying process engineering and automation knowledge to troubleshoot issues, implement CAPA, drive continuous improvement (Lean Six Sigma/Kaizen), ensure cGMP compliance and documentation, and collaborate with operations, quality, and maintenance teams to optimize production.
Summary Generated by Built In
Engineering Experience in Manufacturing Operations – Hands-on experience in process engineering, manufacturing support, or production systems within a regulated environment (biotech, pharmaceutical, or similar).
Technical Knowledge – Familiarity with automation systems, process equipment, and continuous improvement methodologies (Lean Six Sigma, Kaizen, root cause analysis).
Problem-Solving Skills – Demonstrated ability to troubleshoot manufacturing issues, implement corrective/preventive actions (CAPA), and drive process optimization.
Cross-Functional Collaboration – Proven experience working with operations, quality, and maintenance teams to deliver results in a fast-paced environment.
Regulatory / GMP Knowledge – Understanding of cGMP, compliance, and documentation practices for regulated industries.
Additional Strengths – Strong communication, adaptability to change
Requirements
Candidates must have education, years of experience/expertise as follows;
Doctorate,or a Master's degree with 2 years of Manufacturing Operations experience
Bachelor's degree with 4 years of Manufacturing Operations experience
Associate's degree with 8 years of Manufacturing Operations experience
High school/GED with 10 years of Manufacturing Operations experience.
Preferred: Academic background in Engineering disciplines, particularly Chemical Engineering, Mechanical Engineering, Industrial Engineering, or Biotechnology.
Skills Required
- Doctorate, or a Master's degree with 2 years of Manufacturing Operations experience
- Bachelor's degree with 4 years of Manufacturing Operations experience
- Associate's degree with 8 years of Manufacturing Operations experience
- High school/GED with 10 years of Manufacturing Operations experience
- Hands-on experience in process engineering, manufacturing support, or production systems within a regulated environment (biotech, pharmaceutical, or similar)
- Familiarity with automation systems and process equipment
- Knowledge of continuous improvement methodologies (Lean Six Sigma, Kaizen, root cause analysis)
- Demonstrated ability to troubleshoot manufacturing issues, implement corrective/preventive actions (CAPA), and drive process optimization
- Proven experience working with operations, quality, and maintenance teams in a fast-paced environment
- Understanding of cGMP, compliance, and documentation practices for regulated industries
- Strong communication skills and adaptability to change
- Preferred: Academic background in Engineering disciplines (Chemical, Mechanical, Industrial) or Biotechnology
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The Company
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
