Act as Process Engineer in carrying out assigned process-related improvement projects in compliance with safety and regulatory requirements during all phases of assigned projects. The role will support the design, procurement, installation of GMP process equipment supporting vaccine manufacturing operations. In addition, the engineer will work closely with internal customers to provide and/or facilitate engineering support for Formulation and Filling operations.
- Subject Matter Expert (SME) for Formulation/Filling process equipment, including isolator technology. Equipment include: formulation vessels, microfluidizer, syringe filling machine, e-Beam sterilizer and isolators.
- Troubleshoots complex equipment related issues and develops sound engineering solutions to address identified problems for assigned systems
- Routinely interact with internal manufacturing, QA, MS&T, validation, and EHS personnel to achieve project and production goals
- Supports site reliability efforts by monitoring of key equipment performance variables and proactively identifies and addresses issues before they cause unplanned equipment downtime
- Engage with both internal maintenance personnel and external vendors for issue resolution
- Performs engineering tasks for the design, procurement, fabrication and/or commissioning phases associated with standard or custom build biotech systems
- Independently leads small to medium engineering projects.
- Initiate and own change controls for equipment modifications
- Equipment lead for (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence.
- Lead for the execution of start-up and commissioning activities for equipment upgrades
- Participate in site audits by health authorities or other regulatory agencies (e.g. OSHA)
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering or equivalent preferred with at least 3-5+ years of experience in cGMPs and manufacturing operations in an FDA regulated facility.
- Process Engineering experience with parenteral/aseptic processing is a most.
- Experience with the procurement, installation and validation of sterile single use systems.
- Strong communication skills with customers, design teams, contractors, and management.
- Good problem solving, technical learning, time management and prioritizing skills.
- Troubleshooting experience with complex equipment related issues developing sound engineering solutions.
- Enable and support the Ethics & Compliance team at all levels within the organization, and proactively model ethical behaviors consistent with CSL Values: Patience Focus, Innovation, Integrity, Collaboration and Superior Performance.
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
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