Lead Mfg Eng: Process Improvement & Validation

Validation & Engineering Group; Humacao (PR); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading services supplier in the pharmaceutical sector is seeking a Senior Manufacturing Engineer in Humacao, Puerto Rico. The ideal candidate will lead and support manufacturing operations, provide technical guidance, and drive process improvements. Applicants should have a minimum of 5 years in manufacturing engineering, demonstrate leadership capabilities, and possess strong skills in problem-solving and statistical analysis. This role is critical for ensuring compliance with GMP standards and facilitating operational efficiency.

Qualifications

• Minimum of 5 years of experience in manufacturing engineering.
• Proven experience in process improvement initiatives and statistical analysis.
• Strong background in validations and development of IQ/OQ/PQ protocols.

Responsibilities

• Lead and support manufacturing operations across designated areas.
• Provide technical guidance and mentorship to Associate Engineers and COOPs.
• Manage and execute manufacturing projects, ensuring alignment with quality and compliance standards.
• Drive process improvements using engineering methodologies and statistical analysis.
• Support and lead validation activities, including protocol development and execution (IQ/OQ/PQ).
• Collaborate cross-functionally to solve complex technical and manufacturing challenges.

Skills

Manufacturing engineering

Process improvement

Statistical analysis

Leadership

Problem-solving

Job description

Validation & Engineering Group, Inc.(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Job Description

We are seeking a highly skilledSenior Manufacturing Engineerto join our team. The selected candidate will play a key leadership role across multiple manufacturing areas, providing technical expertise, driving process improvements, and mentoring Associate Engineers and COOP students.

Responsibilities:

• Lead and support manufacturing operations across designated areas.
• Provide technical guidance and mentorship to Associate Engineers and COOPs.
• Manage and execute manufacturing projects, ensuring alignment with quality and compliance standards.
• Drive process improvements using engineering methodologies and statistical analysis.
• Support and lead validation activities, including protocol development and execution (IQ/OQ/PQ).
• Collaborate cross-functionally to solve complex technical and manufacturing challenges.
• Ensure compliance with GMP and company standards while achieving operational efficiency.

Qualifications

• Minimum of 5 yearsof experience in manufacturing engineering.
• Proven experience in process improvement initiatives and statistical analysis.
• Strong background in validations and development of IQ/OQ/PQ protocols.
• Demonstrated leadership and mentoring capabilities.
• Excellent problem-solving, organizational, and communication skills.

Additional Information

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