3391 IT & Software Developer jobs in the US
Senior Global Engineering Specialist - Bulk
$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 a related field).
- Masters degree or MBA preferred.
- Over 7 years of experience in reliability engineering, maintenance engineering, or asset management in a regulated environment such as manufacturing, pharmaceuticals, or chemicals.
- At least 5 years supporting bulk biologics manufacturing (upstream and/or downstream).
- Extensive experience managing globally distributed teams and influencing senior stakeholders in complex organizations.
- In-depth knowledge of bulk biologics manufacturing processes (USP/DSP).
- Experience in maintaining bioreactors, chromatography systems, filtration skids, and CIP/SIP systems essential for bulk biotech operations.
- Understanding the impact of maintenance on process consistency and product quality.
- Familiarity with global or multi-site technical support is preferred.
- Strong technical expertise in root cause analysis, predictive diagnostics, risk management, and equipment lifecycle management.
- Experience in facilitating training, workshops, or capability development programs.
- Willingness to travel internationally based on business needs.
- Knowledge of Six Sigma/Lean principles is a plus.
- A strategic thinker with a proactive approach to problem-solving.
- Strong analytical abilities that support data-driven decision-making and prioritization of global reliability risks.
- Innovative mindset that encourages new technologies, advanced diagnostics, and continuous improvement in asset performance.
- Capability to lead change, influence without formal authority, and promote alignment across a complex global framework.
- Exceptional communication skills suitable for diverse stakeholder engagement.
- Proficient in cross-cultural collaboration with the ability to effectively connect with teams from different regions.
- Strong problem-solving and decision-making skills with a focus on maintaining reliability, business continuity, and sustainable performance.
- Commitment to upholding CSLs values, ethical behavior, inclusive teamwork, and fostering a positive, respectful culture.
Responsibilities
- Act as the global subject matter expert for maintenance and reliability in bulk biotech manufacturing areas (both upstream and downstream).
- Create and uphold global maintenance standards for bulk process equipment, utilities, and support systems.
- Establish preventive, predictive, and condition-based maintenance strategies that meet GMP and product quality standards.
- Oversee asset lifecycle management, obsolescence planning, and spare parts strategies for essential bulk manufacturing equipment.
- Offer technical expertise for the maintenance, troubleshooting, and efficiency optimization of bioreactors, media and buffer preparation systems, chromatography skids, filtration systems, and harvest systems.
- Ensure maintenance methods do not compromise product quality or lead to cross-contamination.
- Provide specialized maintenance support for utilities crucial to bulk biotech operations, including clean steam, WFI, PW, process gases, and thermal systems.
- Guarantee that utility maintenance aligns with process consistency and regulatory standards.
- Assure maintenance programs adhere to FDA 21 CFR Parts 210/211, EU GMP, and ICH guidelines.
- Assist with qualification and requalification tasks influenced by maintenance activities.
- Serve as an engineering subject matter expert during regulatory inspections and internal audits.
- Review and authorize maintenance SOPs, change controls, deviations, and risk assessments.
- Assist manufacturing sites with deviation investigations and root cause analysis regarding major failures and implement corrective actions.
- Lead root cause analysis and sustainable corrective action implementations.
- Promote initiatives for continuous improvement aimed at enhancing equipment uptime, reliability, and maintenance efficiency while ensuring GMP compliance.
- Collaborate with Quality, MS&T, Automation, Process Engineering, and Operations teams globally.
- Provide mentoring and technical coaching to site maintenance and reliability teams.
- Encourage knowledge sharing and harmonization of best practices across the global network.
- Support the deployment and optimization of CMMS/EAM systems.
- Define key performance indicators for maintenance effectiveness, including equipment availability and compliance metrics.
- Utilize data and analytics to enhance predictive maintenance practices.
- Carry out any additional duties as assigned by supervisors or members of the Global Leadership Team to meet evolving business needs and foster cross-functional collaboration.
Description
We are CSL Behring, a leading global biotherapeutics company committed to saving lives through innovative therapies. We focus on meeting patient needs by leveraging advanced technologies in the immunology, hematology, cardiovascular, metabolic, respiratory, and transplant therapeutic areas. Our prime scientific platforms include plasma fractionation, recombinant protein technology, and cell and gene therapy, which enable us to continually innovate and refine our products to address unmet medical needs. Based in Melbourne, Australia, we employ around 32,000 individuals and deliver lifesaving therapies across more than 100 countries. We prioritize a culture of inclusion and belonging, emphasizing diversity, curiosity, and empathy to enhance our connection with patients and donors, while also driving our company forward. For more details about our benefits and commitment to well-being, visit our website.
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