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Senior Engineering Specialist - Fractionation
$75,000 - 105,000
CSL Behring
West 8th Avenue 1020, King of Prussia
$75,000 - 105,000
Requirements
Must:
- Bachelors degree in Engineering (Mechanical, Chemical, Electrical, Biomedical, or related field).
- Masters degree is preferred.
- 7+ years of experience in reliability engineering or maintenance engineering within a regulated industry such as manufacturing, pharmaceuticals, or chemicals.
- 7+ years of experience in fractionation or plasma-derived biologics manufacturing.
- Proven track record in managing globally distributed teams and influencing senior stakeholders in complex environments.
- Extensive knowledge of fractionation processes and large-volume biologics production.
- Experience maintaining centrifuges, cold systems, and solvent-based processes.
- Familiarity with utilities and equipment in hazardous areas (ATEX).
- Understanding of maintenances impact on viral safety and product quality.
- Global or multi-site technical support experience is an advantage.
- Strong skills in root cause analysis, predictive diagnostics, risk management, and equipment lifecycle management.
- Experience in training, workshops, or capability development is preferred.
- Willingness to travel worldwide based on business needs.
- Knowledge of Six Sigma/Lean principles is a plus.
- A strategic mindset with proactive problem-solving capabilities.
- Strong analytical skills to support data-driven decision-making and prioritization of global reliability risks.
- Innovative outlook to enhance technology use and asset performance.
- Ability to lead change and influence across a complex global matrix.
- Exceptional communication skills to convey clear and impactful messages to diverse audiences.
- Cross-cultural collaboration abilities to effectively engage with teams across various regions.
- Strong problem-solving and decision-making skills emphasizing long-term reliability and sustainable performance.
- Commitment to upholding CSL values, ethical standards, and fostering an inclusive environment.
Responsibilities
- Act as the global Subject Matter Expert for maintenance and reliability in fractionation biotech operations.
- Create and uphold global maintenance metrics for fractionation equipment and associated infrastructure.
- Establish preventive, predictive, and condition-based maintenance strategies that align with GMP standards and product quality requirements.
- Oversee asset lifecycle management and develop obsolescence and spare parts plans for key fractionation equipment.
- Provide technical guidance for maintenance and troubleshooting of fractionation tanks, large-volume vessels, centrifuges, and related systems.
- Ensure maintenance practices prioritize viral safety, yield, and consistent process outcomes.
- Offer expertise on utilities essential for operations, including refrigeration and freezing systems, clean steam, and solvent recovery systems.
- Ensure operations comply with regulatory requirements in ATEX or hazardous areas as applicable.
- Guarantee that maintenance programs align with FDA and EU GMP regulations for plasma-derived products.
- Assist in qualification activities informed by maintenance tasks.
- Serve as an engineering authority during regulatory inspections and internal audits.
- Approve maintenance SOPs, change controls, deviations, and risk assessments.
- Support manufacturing sites in investigating deviations and conducting root cause analyses related to failures.
- Drive root cause analysis and the establishment of long-term corrective actions.
- Promote continuous improvement initiatives that enhance equipment reliability and compliance.
- Collaborate globally with Quality, MS&T, Automation, Process Engineering, and Operations teams.
- Mentor and provide technical coaching to maintenance and reliability teams.
- Foster knowledge sharing and standard practices across the global network.
- Facilitate the deployment and enhancement of CMMS/EAM systems such as SAP PM or Maximo.
- Set KPIs for maintenance performance, focusing on equipment availability and compliance trends.
- Utilize data analytics to advance predictive maintenance efforts.
- Complete additional tasks as assigned by supervisors or leadership, ensuring support for evolving business needs and cross-functional teamwork.
Description
At CSL Behring, we are a global leader in biotherapeutics dedicated to saving lives. Our mission revolves around using the latest technologies to create innovative therapies for patients facing health challenges in various therapeutic areas including immunology and hematology. We harness advanced scientific methods such as plasma fractionation and recombinant protein technology to continuously enhance our product offerings and respond to unmet medical needs. Headquartered in Melbourne, Australia, CSL operates one of the largest plasma collection networks globally, employs a workforce of 32,000, and delivers life-saving therapies to over 100 countries. We are committed to fostering an inclusive and diverse workplace, recognizing that our differences fuel innovation. We actively promote a culture that encourages curiosity and empathy, ultimately benefiting our patients and stakeholders. For more information about our benefits and commitment to inclusion, please visit our website.
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