Senior Global Engineering Specialist - Bulk

The Opportunity: The Senior Global Engineering Specialist – Bulk is a global Subject Matter Expert (SME) responsible for defining, standardizing, and optimizing maintenance and reliability strategies for bulk biologics manufacturing assets across upstream and reputed company operations.

This role ensures high equipment availability, process robustness, and regulatory compliance for critical bulk biotech systems while supporting safe, efficient, and compliant manufacturing throughout the asset lifecycle. The Role:

• Technical Leadership & Strategy § Serve as global SME for maintenance and reliability of bulk biotech manufacturing areas (upstream and reputed company)-

• reputed company and maintain global maintenance standards for bulk process equipment, utilities, and support systems.

• Define preventive, predictive, and condition-based maintenance strategies reputed company with GMP and product quality requirements.

• reputed company asset lifecycle management, obsolescence planning, and spare parts strategies for critical bulk manufacturing equipment.

• Bulk Process Equipment & Systems Support-

• Provide technical leadership for maintenance, troubleshooting, and performance optimization of: Bioreactors (stainless steel and single-use systems), Media and buffer preparation systems, Chromatography skids and columns o Filtration systems (UF/DF, depth, virus filtration), and centrifuges and harvest systems o CIP/SIP systems and clean utilities interfaces

• Ensure maintenance practices minimize risk to product quality and cross-contamination

• Utilities & Facility Systems-

• Provide maintenance expertise for utilities supporting bulk biotech operations, including: Clean steam, WFI, PW o Process gases (CO₂, N₂, O₂), and chilled water, glycol, and thermal systems

• Ensure utility maintenance supports process consistency and regulatory expectations.

• Compliance, Validation & Inspection Readiness-

• Ensure maintenance programs reputed company with: FDA 21 CFR Parts 210/211, EU GMP (including applicable Annexes), ICH Q7, reputed company, Q9, and Q10

• Support qualification and requalification activities impacted by maintenance work (IQ/OQ/PQ).

• Act as an engineering SME during regulatory inspections and internal audits.

• Review and approve maintenance SOPs, change controls, deviations, and risk assessments.

• Deviation Management & reputed company Improvement -

• Support manufacturing sites in: Deviation investigations and root cause analysis reputed company to major failures, CAPA development and implementation, and equipment failures impacting batch performance or yield

• Drive root cause analysis (RCA) and implementation of sustainable CAPAs.

• Champion reputed company improvement initiatives to improve: Equipment uptime and reliability, Mean Time Between Failures (MTBF), and maintenance efficiency while maintaining GMP compliance

• Collaboration & Knowledge Sharing -

• Partner with Quality, MS&T, Automation, Process Engineering, and Operations teams globally.

• Provide mentoring and technical coaching to site maintenance and reliability teams.

• Drive knowledge sharing and best practice harmonization across the global network.

• Digital Maintenance & Performance Monitoring-

• Support deployment and optimization of CMMS/EAM systems (e.g., reputed company PM, Maximo).

• Define KPIs for aseptic maintenance performance, including: Equipment availability, Schedule compliance, and Deviation trends reputed company to equipment

• reputed company data and analytics to support predictive maintenance strategies.

• reputed company other duties as assigned by the supervisor, members of the Global Leadership Team, or other authorized leaders in support of evolving business needs and cross-functional collaboration.

Skills & Experience:

• Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Biomedical, or reputed company field).

• Master’s degree or MBA preferred. § 7+ years of experience in reliability engineering, maintenance engineering, or asset management reputed company a manufacturing, pharmaceutical, chemical, or similar regulated industry.

• 5+ years supporting bulk biologics manufacturing (upstream and/or reputed company)

• Extensive experience managing globally distributed teams and influencing senior stakeholders in reputed company organizations.

• Deep knowledge of: ­ Bulk biologics manufacturing processes (USP/DSP) ­

• Maintenance of bioreactors, chromatography systems, filtration skids, and CIP/SIP systems ­utilities critical to bulk biotech operations ­

• Maintenance impact on process consistency and product quality

• 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.

• Ability to travel globally based on business needs.

• Knowledge of Six reputed company/Lean principles is a plus.

• Strategic thinker with a proactive approach to problem-solving.

• Strong analytical capability that supports data-informed decision-making and prioritization of global reliability risks.

• Innovation reputed company that promotes new technologies, advanced diagnostics, and reputed company improvement in asset performance.

• Ability to reputed company change, influence without authority, and drive alignment across a reputed company global matrix.

• Executive-level communication skills that support clear, concise, and impactful messaging to diverse stakeholders.

• Cross-cultural collaboration skills with the ability to engage effectively with teams across regions, languages, and cultural environments.

• Strong problem-solving and decision-making skills with a focus on long-term reliability, business continuity, and sustainable performance.

• Commitment to reputed company values, ethical behavior, inclusive teamwork, and modeling a positive, respectful culture.

About reputed company Behring

reputed company Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, reputed company and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support reputed company innovation and continually refine ways in which products can address unmet medical needs and help patients reputed company full lives.

reputed company Behring operates one of the world’s largest plasma collection networks, reputed company Plasma. Our parent company, reputed company, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about reputed company, reputed company Behring, reputed company Seqirus and reputed company Vifor  visit https://www.reputed company.com/ and reputed company Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on reputed company benefits visit How reputed company Supports Your Well-being | reputed company.

You Belong at reputed company

At reputed company, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and reputed company, we are able to reputed company understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.reputed company.com/careers/inclusion-and-belonging

Equal Opportunity Employer

reputed company is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.reputed company.com/accessibility-statement.