Job Summary: We are seeking an Engineer to support biopharmaceutical process equipment and facility systems within a highly regulated manufacturing environment. This role offers the opportunity to contribute to equipment reliability, technical problem-solving, and the introduction of new technologies that help ensure production runs smoothly and efficiently.

Responsibilities:

Provide system ownership for biopharmaceutical process equipment and support improvements, upgrades, and modifications to equipment or facility systems.

Develop business cases, identify design requirements, and support equipment design, specification, construction, startup, and validation activities.

Direct and coordinate equipment maintenance, monitor system performance, and implement risk reduction strategies to help reduce downtime.

Support root cause analysis, corrective and preventive actions, commissioning and qualification, and engineering assessments for new product or technology introductions.

Required:

Bachelor’s degree in Chemical or Mechanical Engineering preferred, or another qualifying degree path listed in the job description.

4+ years of relevant work experience with 2+ years in a biopharmaceutical operations/manufacturing environment preferred.

Experience working in a regulated environment such as cGMP, OSHA, or EPA, with familiarity in GMP quality systems including change control, non-conformances, CAPA, and qualifications/validation.

Ability to analyze problems and develop engineering solutions using data-driven methods such as RCA, SPC, Six Sigma, and predictive maintenance.

Technical troubleshooting ability, including reading and understanding technical documents, P&IDs, and electrical drawings.

Ability to collaborate effectively with diverse teams and adapt to support where needed.

About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.

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