Senior Process Engineer
2 weeks ago
Position: Senior Process Engineer
Location: Not Specified
Duration: Long-term Contract
Overview:
This engineering role is pivotal in enhancing manufacturing operations related to process equipment. The engineer collaborates closely with maintenance teams, project managers, and manufacturing personnel to ensure the optimal performance and reliability of equipment.
Key Responsibilities:
- Identify and spearhead engineering enhancements or upgrades to equipment systems, translating design requirements into actionable specifications.
- Champion Lean methodologies to drive operational excellence, documenting opportunities for cost reduction, safety improvements, and efficiency gains.
- Take ownership of verification deliverables for significant capital projects.
- Coordinate maintenance activities to ensure equipment functionality and reliability.
- Oversee verification tasks performed by contracted verification personnel.
- Formulate commissioning and functional testing plans for equipment modifications.
- Prioritize safety during all phases of commissioning, validation, and manufacturing processes.
- Assist Manufacturing and Quality Assurance with Performance Qualification (PQ) tasks as necessary.
- Act as a liaison between engineering and manufacturing teams throughout project phases.
- Monitor systems to detect performance risks and devise strategies for risk mitigation.
- Provide problem-solving expertise to minimize production downtime, leading technical root cause analyses as needed.
- Support the introduction of new products and technologies through engineering assessments and modifications.
- Ensure compliance with environmental health and safety regulations during equipment operation.
- Offer technical support and guidance to manufacturing and maintenance teams.
- Mentor project teams on risk-based approaches to commissioning and verification.
- Contribute to the development and maintenance of performance metrics.
- Willingness to travel domestically for training purposes.
- Full-time onsite presence is required, with flexibility to support operations as needed.
Preferred Qualifications:
- Bachelor's degree in Chemical Engineering or related field.
- 6+ years of relevant experience in biopharmaceutical manufacturing environments.
- Experience in regulated settings (e.g., cGMP, OSHA).
- Familiarity with GMP quality systems and processes.
- Proficient in troubleshooting and design of biopharmaceutical production equipment.
- Strong analytical skills with a focus on data-driven problem-solving.
- Demonstrated ability to work independently and collaboratively in a team-oriented culture.
Basic Qualifications:
Doctorate degree OR Master’s degree with 3 years of experience OR Bachelor’s degree with 5 years of experience OR Associate degree with 10 years of experience OR High school diploma/GED with 12 years of experience.
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