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Senior Global Engineering Specialist - Aseptic Tech
$75,000 - 105,000
CSL Behring
West 8th Avenue 1020, King of Prussia
$75,000 - 105,000
Requirements
Must:
- Bachelors degree in engineering (Mechanical, Electrical, Chemical, or related)
- Masters degree or MBA preferred
- Over 7 years of experience in reliability engineering, maintenance engineering, or asset management within a manufacturing, pharmaceutical, chemical, or similar regulated industry
- More than 5 years supporting aseptic or sterile manufacturing areas
- Extensive experience managing globally distributed teams and influencing senior stakeholders in complex organizations
- Deep knowledge of aseptic manufacturing and sterility assurance principles
- Maintenance experience with isolators, RABS, filling lines, and cleanroom systems
- Understanding of HVAC, HEPA filtration, and sterile utilities maintenance impact on contamination control strategies
- Experience with global or multi-site technical support preferred
- Strong technical capability in root cause analysis, predictive diagnostics, risk management, and equipment lifecycle management
- Experience facilitating training, workshops, or capability development programs
- Willingness and ability to travel globally based on business needs
- Knowledge of Six Sigma/Lean principles is a plus
- Strategic thinker with a proactive approach to problem-solving
- Strong analytical capability that supports data-informed decision-making
- Innovative mindset that promotes new technologies and continuous improvement in asset performance
- Ability to lead change and influence without authority
- Executive-level communication skills for effective messaging
- Cross-cultural collaboration skills
- Strong problem-solving and decision-making skills focused on long-term reliability
- Commitment to CSL values and ethical behavior
Responsibilities
- Hold the position of global Subject Matter Expert for maintenance of aseptic manufacturing areas and sterile assets.
- Create and uphold global maintenance standards for aseptic equipment and clean environments.
- Establish preventive, predictive, and condition-based maintenance strategies in accordance with GMP and sterility assurance requirements.
- Oversee asset lifecycle management, obsolescence planning, and spare parts strategies for critical aseptic systems.
- Provide technical support for the maintenance and troubleshooting of various aseptic systems including filling lines and cleanroom HVAC systems.
- Ensure maintenance tasks uphold cleanroom classifications and contamination control.
- Align maintenance programs with regulatory guidelines such as FDA 21 CFR Parts 210/211 and EU GMP Annex 1.
- Assist with qualification and requalification processes impacted by maintenance activities.
- Act as an engineering expert during regulatory inspections and audits.
- Review and authorize maintenance SOPs, change controls, and technical risk assessments.
- Support manufacturing sites with deviation investigations related to aseptic failures and equipment breakdowns.
- Lead root cause analysis and the implementation of effective corrective actions.
- Advocate for continuous improvement measures to enhance equipment uptime and reliability.
- Collaborate with various teams globally to share best practices and contribute to engineering expertise.
- Mentor site engineers and technical teams to foster skills development.
- Assist in the deployment and optimization of CMMS/EAM systems.
- Define KPIs for aseptic maintenance performance and leverage data for predictive maintenance.
- Execute any additional duties as assigned by leadership to support business needs and collaboration efforts.
Description
At CSL Behring, we are a dedicated global leader in biotherapeutics, committed to saving lives through innovative therapies across multiple medical fields. Our focus on patient needs drives our use of cutting-edge technologies in the development and delivery of our solutions. We operate one of the largest plasma collection networks globally and are supported by a robust workforce of 32,000 employees, enabling us to provide essential therapies to individuals in over 100 countries. We prioritize inclusivity and belonging in our workplace, recognizing that diverse contributions enhance our innovation and service. For more details on our commitment to well-being and our company culture, please visit our website. Join us in making a significant impact in the healthcare industry.
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