Project Engineering, Associate Director

This role is accountable for the end-to-end execution of complex capital projects (T2&T3) within a cGMP-regulated environment ensuring delivery aligned with business priorities regulatory expectations and CSLs engineering and quality standards. The Project Engineering Associate Director partners cross-functionally to translate strategic objectives into executable projects that enhance capacity capability and compliance across the manufacturing.

Role that this position reports to: Head of Project Engineering

Main Responsibilities and Accountabilities:

Engineering Leadership

Provide strategic and technical leadership across engineering disciplines including process mechanical electrical automation and facilities.

Ensure engineering solutions are robust scalable and compliant with cGMP ISPE and internal CSL standards.

Review and approve key engineering deliverables (e.g. URS design specifications P&IDs technical packages).

Support technology transfers process improvements and facility expansions.

Project Delivery & Execution Excellence

Lead the full lifecycle of capital projects (typically $1MM$50MM) from concept through design procurement construction commissioning and qualification (CQV).
Translate business needs into clearly defined project scopes timelines and resource plans.
Ensure consistent application of CSL project management standards governance and stage-gate processes.
Proactively manage risks issues and change controls to ensure predictable project outcomes.

Quality & Compliance

Ensure all project activities meet global regulatory requirements (FDA EMA) and CSL Quality standards.
Oversee commissioning qualification and validation strategies (IQ/OQ/PQ) to ensure inspection readiness.
Partner with Quality and Validation to maintain a state of compliance throughout project execution.

Stakeholder Partnership
Serve as a trusted partner to Engineering Manufacturing Quality Supply Chain Validation and EHS functions.
Provide clear data-driven updates to senior leadership on project status risks and financial performance.
Build and manage effective relationships with external partners including EPC firms OEMs and contractors.

Safety Health & Environment (EHS)
Champion a zero-harm safety culture across all project phases ensuring safety is the top priority in design and execution.
Ensure compliance with all applicable EHS regulations (OSHA EPA) and CSL global safety standards.
Integrate safety-by-design principles (e.g. risk assessments safety work permits) into engineering and project delivery.
Lead contractor safety management including prequalification onboarding and on-site oversight.
Ensure robust incident prevention reporting and corrective action processes are in place.
Partner with EHS to ensure safe execution during construction commissioning and startup activities.

Financial Stewardship
Develop manage and forecast capital expenditure (CapEx) budgets in alignment
with approved business cases.
Drive disciplined cost management and identify opportunities for efficiency without
compromising safety or quality.
Ensure transparency in financial reporting and adherence to CSLs financial control

People Leadership & Culture
Lead coach and develop a high-performing team of project engineers and external resources.
Foster a culture of accountability inclusion safety and continuous improvement consistent with CSL values.
Build organizational capability through mentoring and talent development.

Operational Excellence
Champion standardization and continuous improvement in project delivery processes.
Apply Lean and Six Sigma principles to improve efficiency and reduce variability.
Promote a strong safety culture and ensure EHS requirements are embedded in all project activities.

Education:

Bachelors degree in engineering (Chemical Mechanical Electrical or related discipline) required.
Advanced degree (MS or MBA) preferred.

Experience:

10 years of engineering experience in Biotech Pharma or regulated life sciences.
5 years of experience leading capital projects in a cGMP-regulated manufacturing environment.
Demonstrated success delivering complex cross-functional projects.
Strong knowledge of pharmaceutical manufacturing processes (e.g. fractionation bulk processing fill/finish packaging).
Expertise in critical utilities and facilities systems (HVAC WFI clean steam process gases).
Familiarity with automation and control systems (e.g. PLC SCADA).
Deep understanding of commissioning qualification and validation (CQV) lifecycle.
Strategic thinker with the ability to translate complex engineering challenges into actionable programs.

Competencies:

Demonstrated ability to lead through influence and drive alignment across functions.
Strong decision-making and problem-solving skills in complex environments.
Excellent communication skills with the ability to engage effectively at all levels of the organization.
Strategic mindset with strong execution discipline.
Financial Acumen & ROI-oriented mindset
Commitment to CSL values ethical behavior inclusive teamwork and modeling a positive respectful culture.
PMP (Project Management Professional)
Lean Six Sigma (Green Belt or higher)
Professional Engineer (PE) license

The expected base salary range for this position at hiring is $173000- $205000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications skill level experience competencies and other relevant addition to base salary total compensation for this role may also include incentive compensation and equity.

About CSL Behring

CSL 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 develop 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 continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL 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 empathy we are able to better 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 Opportunity Employer

CSL 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 Experience:

Director