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Engineer
Job Description
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What you will do
In this role, the Engineer will report to the Senior Manager of the Process Engineering group and will provide daily engineering support to the site.
Responsibilities include:
- Serve as system owner for process equipment and systems supporting manufacturing operations.
- Provide engineering support for design, construction, startup, commissioning, and qualification of new or modified systems.
- Identify and/or lead implementation of small-to-medium scale equipment or facility improvements, including development of business cases.
- Develop maintenance programs, ensure spare part availability, and coordinate execution to maintain system reliability.
- Ensure systems operate safely and in compliance with EHS standards and regulations.
- Support commissioning and qualification activities in alignment with GMP requirements and regulatory inspections.
- Apply engineering principles in daily operations, maintenance, and troubleshooting of plant systems.
- Monitor system performance and implement risk-reduction strategies.
- Lead or support troubleshooting efforts to minimize production downtime, including root cause analysis and CAPA implementation.
- Support new product and technology introductions via engineering assessments, equipment modifications, and pilot runs.
- Advance use of predictive maintenance and condition-based monitoring using data analytics where applicable.
- Lead or contribute to deviation investigations and other quality-related processes.
- Analyze and present findings related to operational issues and engineering projects.
- Provide technical support to commercial and clinical manufacturing, specifically in process control and equipment.
- Collaborate with cross-functional groups such as manufacturing, process development, utilities, maintenance, quality, and validation to drive operational improvements.
- Maintain regular communication with leadership and team members, escalating issues with proposed solutions.
- Participate in a small engineering team on a project or ongoing support basis.
- Provide rotational on-call support for utility systems, including nights, weekends, and holidays as needed.
- Participate in the design and selection of systems, instrumentation, and components.
- Evaluate supplier capabilities and assess new technologies to improve cost, throughput, or technical capabilities.
Win
What we expect of you
We value diverse perspectives and contributions. The engineering professional we seek is dynamic, adaptable, and team-oriented, with the following qualifications:
Preferred Qualifications:
- Bachelors degree in Chemical or Mechanical Engineering.
- 6+ years of relevant work experience, including 5+ years in a biopharmaceutical manufacturing environment.
- Hands-on experience with GMP production equipment such as bioreactors, centrifuges, filtration systems, and purification technologies.
- Proficiency with equipment and facility control systems, including troubleshooting and logic understanding.
- Experience in regulated environments (e.g., cGMP, OSHA, EPA) and knowledge of quality systems (e.g., change control, non-conformances, CAPA, validation).
- Strong communication, technical writing, and presentation skills; ability to work independently.
- Proven team collaboration and facilitation skills.
- Analytical thinking with the ability to interpret complex problems using multiple data sources.
- Ability to support capital projects and implement process improvements.
- Understanding of capital project execution from procurement through validation in GMP environments.
- Commitment to safety and compliance in all engineering activities.
- Self-starter with excellent organization, time management, and multitasking skills.
- Willingness to work flexible hours in support of 24/7 manufacturing operations.
Pay rate range: $30-37/hr depending on experience
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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