Job Description

The Project Production Specialist serves as the manufacturing shopfloor process owner, beginning in the project design phase and transitioning into the owner of process execution and performance at the shopfloor level for an assigned licensed manufacturing area.

This role ensures manufacturing processes are operationally effective, standardized, and consistently executed in alignment with established process design, and ultimately are controlled and continuously improved to deliver safe, compliant product supply.

The role translates process design and scientific intent-developed with MS&T-into sustainable manufacturing practices, builds operator capability, and ensures effective day-to-day execution. MS&T retains accountability for process science and complex technical decisions.

Design Phase:

-Serve as Manufacturing representative for shopfloor execution and usability, representing operations during design activities

-Review and approve:

• Process design documents, P&IDs, URS, and control strategies
• Facility and equipment layout for operability, safety, and maintainability

-Ensure design supports:

• Operator usability and human factors
• Cleanability, changeover, and maintenance access
• Data collection and process monitoring capabilities

-Partner cross-functionally with:

• Engineering, Quality, MS&T, Automation, Global SMEs, and various business partners

-Identify risks early and ensure mitigation strategies are embedded in design.

-Ensure process designs are executable, observable, and sustainable in a manufacturing environment

-Ensure alignment with regulatory requirements and CSL manufacturing standards.

Procurement (Build) and Testing Phase:

-Provide process execution and usability input during equipment fabrication, installation, and testing.

-Verify:

• Equipment and systems meet process requirements and design intent
• Control strategies are correctly implemented

-Support FAT/SAT and commissioning readiness.

-Ensure process monitoring and data capture systems are functional.

-Identify and resolve gaps between design and execution.

-Begin development of Standard Operating Procedures (SOPs), batch records and execution documentation.

Commissioning, Qualification, and Validation (CQV) Phase:

-Act as shopfloor process representative during IQ/OQ/PQ and process validation execution

-Ensure:

• Process parameters and control ranges are appropriately defined and executable in operations.
• Data collection supports operational monitoring and regulatory expectations

- Verify data integrity, completeness, and alignment with expected operational performance.

-Support development of control strategies and response plans.

-Ensure documentation reflects validated process conditions.

-Collaborate with MS&T, Quality and Validation to ensure compliance readiness.

Operational Readiness and Start-up:

-Lead shopfloor process readiness for manufacturing operations.

-Finalize and own SOPs, batch records, and process documentation.

-Support operator training on execution, critical steps, and troubleshooting.

-Establish standard work and visual management systems.

-Ensure operators understand process intent, normal conditions, and failure signals.

-Support initial production runs and troubleshoot process issues.

-Ensure inspection readiness.

-Own operator capability development and readiness to execute the process independently.

-Lead structured, shopfloor-level problem solving prior to escalation to MS&T.

Licensure (Manufacturing Department Management):

-Serve as primary owner of process execution, adherence, and performance at the shopfloor level.

-Monitor process performance using input, process, and output metrics.

-Own and update SOPs, batch records, and relevant documentation.

-Lead or support investigations and CAPAs.

-Drive shopfloor continuous improvement focused on standardization, waste reduction, and operator effectiveness.

-Act as shopfloor SME during inspections and audits.

-Collaborate cross-functionally to sustain safety, quality, and supply reliability.

-Escalate complex, cross-process, or science-driven issues to MS&T for ownership and technical leadership.

Lifecycle Management and Continuous Improvement:

-Collaborate with Continuous Improvement and Operational Excellence to identify and implement process optimizations and improvements at the shopfloor level.

-Ensure improvements are documented, standardized, and sustained.

-Monitor long-term trends to detect drift and emerging risks.

-Support technology transfers and process changes.

-Partner with MS&T to implement changes aligned to evolving process understanding, regulatory requirements, and business strategy.

-Identify and escalate higher-value or cross-value stream improvement opportunities to MS&T.

Education
• Bachelor's Degree (Engineering or Science preferred). Relevant manufacturing leadership experience in GMP operations and capital projects may be acceptable in lieu of an Engineering or Science degree.

Experience
• 5+ years manufacturing experience in pharmaceutical, biotechnology, or biological industry.
• Experience with production technologies (equipment and automation systems) necessary.
• Experience supporting capital projects or facility startups.
• Knowledge of CQV processes.
• Experience in a Union manufacturing environment will be considered a plus.
• Proficient in Microsoft Office applications and relevant business information systems.

Competencies
• Technical Expertise: Deep knowledge of GMP manufacturing, process equipment, and regulatory requirements.
• Project Integration: Ability to translate operational needs into design requirements.
• Problem Solving: Strong analytical skills to identify risks and implement solutions.
• Communication: Effective collaboration across Engineering, Quality, and Operations.
• Risk Management: Experience with HAZOP, FMEA, and operational risk identification.
• Continuous Improvement: Lean manufacturing and process optimization mindset.
• Compliance and Safety Focus: Strong understanding of regulatory, quality, and safety standards.
• Resilience: Maintains technical clarity and effectiveness under pressure, successfully navigating uncertainty and dynamic project conditions.

Environment
• Candidate must be able to wear clean room garments and personal protective equipment and meet cGMP gowning requirements to work in manufacturing environments. Work environment may include navigating a large facility as well as operating in a production office. Exposure to various temperatures, hazardous chemicals, and potential bloodborne pathogens. May be required to work overtime and extended hours to support business needs. Some travel (
The expected base salary range for this position at hiring is $95,000 - $119,000. 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 factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable