Industrial Optimization Project Specialist

1. JOB OBJECTIVES

The industrial optimization project specialist is responsible for identifying, analyzing, and closing process gaps within production and associated support areas. The role ensures documentation accuracy, implements sustainable solutions, supports CAPA execution, and contributes to continuous improvement initiatives across sites. The specialist will lead improvement activities, working collaboratively in a multidisciplinary environment.

2. PRIMARY FUNCTIONS

Process Improvement & Execution:

• Identify operational gaps in production and supporting processes and drive the actions required to close them.
• Translate process needs into concrete deliverables (documents, procedures, workflows, tools).
• Ensure that improvements are practical, sustainable, and aligned with sterile manufacturing requirements.
• Coordinate with cross-functional teams to ensure solutions are implemented effectively and on time.

Documentation Ownership & Standardization:

• Lead updates and creation of required documentation (SOPs, forms, batch records, workflows) linked to process improvements.
• Ensure documentation accurately reflects operational reality and supports compliance requirements.
• Harmonize documents and practices across sites.

Continuous Improvement:

• Act as a change agent to improve efficiency, robustness, and compliance in production processes.
• Apply continuous improvement methodologies (Lean, root-cause analysis, standard work, etc.) to identify and resolve issues.
• Monitor the impact of implemented solutions using KPIs and ensure long-term process stability.

CAPA & Compliance Support:

• Participate in non-conformance investigations and propose appropriate CAPA.
• Lead the implementation of CAPA actions related to procedures, documentation, and process improvements.
• Ensure all actions align with GMP and sterile manufacturing expectations.

Cross-functional Coordination:

• Work closely with Production, QA, QC, Engineering, Supply Chain, and other stakeholders to ensure improvements are fully adopted and effective.
• Facilitate alignment meetings, problem-solving discussions, and follow-ups.
• Serve as a key integrator who connects documentation, people, and processes.

Project Leadership:

• Lead and execute assigned improvement projects from initiation to completion, without direct staff management.
• Define timelines, deliverables, responsibilities, and follow-up mechanisms.
• Communicate progress and escalate risks or delays when needed across both sites.

3. TRAINING, QUALIFICATIONS AND EXPERIENCE

• Bachelor’s degree in engineering or science, or relevant experience.
• At least 5 years of experience in the pharmaceutical/biopharmaceutical industry or an equivalent sector.
• Knowledge of project management methods.
• Knowledge of Good Manufacturing Practices (GMP).
• Understanding of structures and manufacturing processes for sterile pharmaceutical products.
• Bilingual (French and English) with excellent written and oral communication skills.
• Proficiency in computer tools, particularly the Microsoft Suite.
• Strong organizational skills.
• Ability to synthesize information for system design and engineering.
• Analytical and problem-solving skills.
• Good interpersonal skills and ability to work collaboratively with peers.
• Sound judgment, entrepreneurial spirit, autonomy, and initiative.
• Ability to lead, guide, and participate in various cross-functional teams.
• Customer satisfaction oriented.
• Ability to work under pressure with tight deadlines and frequent priority changes.