Project Manager – Operational Excellence

Connexion Systems + Engineering; Los Angeles (CA); In loco; USD 59.000 - 65.000; Tempo pieno

Descrizione del lavoro

Connexion Systems & Engineering seeks a Project Manager – Operational Excellence for a 5+ month contract in Los Angeles to lead GMP manufacturing process improvements, qualification, validation, and change control.

The role requires coordinating cross‑functional teams, managing schedules, risks, and regulatory compliance, with onsite support for a 24/7 manufacturing environment.

Competenze

• Bachelor’s degree in Engineering, Biology, Chemistry, Biochemistry, or related field.
• Minimum 5 years in pharmaceutical industry with ≥3 years leading GMP projects.
• Experience managing technical projects in pharma manufacturing processes and equipment.
• Strong knowledge of cGMPs, FDA regulations, validation, QA/QC, change control.
• Ability to lead cross-functional teams and drive projects from planning to closure.
• Willingness to support 24/7 operations.

Mansioni

• Lead multiple pharmaceutical manufacturing projects from process improvements to plant initiatives.
• Develop and maintain project plans, schedules, milestones, and resources.
• Manage projects through initiation, planning, execution, implementation, and closure.
• Drive initiatives on manufacturing capacity expansion, equipment reliability, and quality improvements.
• Identify risks and develop mitigation strategies to keep schedules on track.
• Coordinate cross-functional teams across Manufacturing, Engineering, QA/QC, Validation, Facilities.
• Oversee GMP change control activities and regulatory compliance tasks.
• Support equipment qualification, validation, and regulatory activities.
• Prepare technical docs, status reports, risk assessments for stakeholders.
• Facilitate project meetings and maintain alignment across teams.
• Support continuous improvement and standardization of PM processes.
• Ensure completed projects transition into routine manufacturing.

Conoscenze

GMP experience

Cross-functional leadership

Technical writing

Regulatory knowledge

Project management

cGMP knowledge

Risk management

Formazione

Bachelor's degree in Engineering/Biology/Chemistry/Biochemistry or related field

Descrizione del lavoro

Project Manager – Operational Excellence (Pharmaceutical Manufacturing)

Hiring Organization: Connexion Systems & Engineering

Duration: 5+ months contract, possible extension

Compensation: $43.00–$47.50/hour

Job Location: Los Angeles, CA

Work Model: 100% onsite

Schedule: Monday – Friday, with flexibility to support 24/7 mfg operations

We are seeking an experienced Project Manager – Operational Excellence to lead technical and operational improvement projects within a regulated pharmaceutical manufacturing environment. This role is ideal for a project management professional with a strong background in GMP manufacturing, process improvement, equipment qualification, validation, and change control. The Project Manager will oversee multiple projects supporting manufacturing capacity, equipment reliability, operational efficiency, and regulatory compliance. Working closely with Engineering, Manufacturing, Quality, Validation, and other technical teams, this individual will drive projects from initial planning through successful implementation and closure.

Key Responsibilities

• Lead and manage multiple pharmaceutical manufacturing projects, ranging from process improvements to large-scale plant initiatives.
• Develop and maintain project plans, schedules, milestones, resource allocations, and deliverables.
• Manage projects through initiation, planning, execution, implementation, and closure.
• Drive initiatives focused on manufacturing capacity expansion, equipment reliability, process optimization, and quality improvements.
• Identify project risks, develop mitigation strategies, and proactively resolve obstacles impacting schedules or deliverables.
• Coordinate cross-functional teams, including Manufacturing, Engineering, Quality Assurance, Quality Control, Validation, Facilities, and Maintenance.
• Oversee GMP change control activities, ensuring timely approvals, implementation, and closure.
• Support equipment qualification, validation, and regulatory compliance activities.
• Prepare technical documentation, project status reports, risk assessments, and presentations for stakeholders.
• Facilitate project meetings, establish clear responsibilities, and maintain alignment across technical teams.
• Support continuous improvement initiatives and the standardization of project management processes and procedures.
• Ensure completed projects transition effectively into routine manufacturing operations.

Required Qualifications

• Bachelor's degree in Engineering, Biology, Chemistry, Biochemistry, or a closely related scientific or technical discipline.
• Minimum 5 years of experience in the pharmaceutical industry, including at least 3 years managing projects in a GMP manufacturing environment.
• Demonstrated experience managing technical projects involving pharmaceutical manufacturing processes, facilities, or equipment.
• Knowledge of pharmaceutical manufacturing systems and equipment, such as chromatography, ultrafiltration, Clean-in-Place (CIP) systems, reactor tanks, centrifuges, or similar technologies.
• Strong understanding of cGMP requirements, FDA regulations, validation, equipment qualification, and change control.
• Proven ability to manage project scope, schedules, resources, risks, and competing priorities.
• Experience leading cross-functional technical teams and coordinating projects across multiple departments.
• Strong technical writing, documentation, communication, and problem-solving skills.
• Ability to work independently, exercise sound judgment, and deliver results in a fast-paced manufacturing environment.
• Flexibility to accommodate operational needs within a 24/7 manufacturing facility.

Preferred Qualifications

• Project Management Professional (PMP) certification or formal project management training.
• Experience in biologics, biopharmaceutical, or other complex pharmaceutical manufacturing environments.
• Background in manufacturing engineering, technical operations, validation, or process engineering.
• Experience managing equipment installations, manufacturing capacity expansions, facility upgrades, or process improvement initiatives.
• Familiarity with Lean Six Sigma, continuous improvement methodologies, or PMO governance.

Additional Information

• Location: Los Angeles, CA
• Contract Duration: Approximately 5 months
• Compensation: $43.00–$47.50 per hour
• Schedule: Flexibility required to support a 24/7 manufacturing operation.
• Travel: Occasional domestic travel may be required.