MES Project Manager - Life Sciences

Description:

Experience Required:

8 - 15 years (with 4 - 8 years in MES implementation in Life Sciences)

Role Overview:

We are looking for an experienced MES (Manufacturing Execution System) Project Manager to lead digital manufacturing initiatives in the Life Sciences domain (Pharma / Biotech / Medical Devices). The role involves managing end-to-end MES implementations, ensuring compliance with regulatory standards, and driving operational efficiency across manufacturing sites.

Key Responsibilities:

Project Management:

- Lead end-to-end MES implementation projects (planning, execution, delivery)

- Define project scope, timelines, budgets, and resource allocation

- Manage cross-functional teams (IT, Quality, Manufacturing, Validation)

- Track project progress and ensure timely delivery

MES Implementation:

- Drive implementation of MES platforms such as Siemens Opcenter Execution Pharma, Werum PAS-X, or Rockwell PharmaSuite

- Oversee system configuration, integration with ERP (e.g., SAP S/4HANA), and shop-floor systems

- Ensure alignment with manufacturing processes and digital strategy

Regulatory & Compliance:

- Ensure compliance with GxP, FDA 21 CFR Part 11, and CSV (Computer System Validation) requirements

- Lead validation activities (IQ, OQ, PQ)

- Maintain audit readiness and documentation

Stakeholder Management:

- Act as the primary interface between business, IT, and external vendors

- Manage client expectations and provide regular updates

- Conduct workshops and requirement gathering sessions

Risk & Quality Management:

- Identify project risks and implement mitigation strategies

- Ensure quality standards and best practices are followed

Required Skills & Qualifications:

Education

- Bachelors/Masters degree in Engineering, Life Sciences, or related field

Experience:

- Strong experience in MES implementations in Pharma/Biotech

- Experience managing large-scale digital transformation projects

Technical Skills:

- Hands-on knowledge of MES systems (PAS-X, PharmaSuite, Opcenter, etc.)

- Understanding of integration with ERP, LIMS, SCADA

- Knowledge of manufacturing processes (batch processing, serialization, etc.)

Regulatory Knowledge:

- Strong understanding of GMP, GAMP 5, 21 CFR Part 11

Soft Skills:

- Strong leadership and communication skills

- Stakeholder management and problem-solving ability

- Ability to work in a fast-paced, regulated environment

Preferred Qualifications:

- PMP / PRINCE2 certification

- Experience in global rollouts or multi-site implementations

- Exposure to digital manufacturing / Industry 4.0 initiatives

Key Competencies:

- Leadership & team management

- Strategic thinking

- Risk management

- Execution excellence

KPIs / Success Metrics:

- On-time, within-budget project delivery

- Compliance audit success rate

- User adoption and system performance

- Process efficiency improvements