Director Manufacturing Engineering

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For our client, a large-scale manufacturing company, we are looking for:

Director Manufacturing Engineering

The role of Director Manufacturing Engineering is a strategic and mission-critical leadership position within the organization, with direct responsibility for overseeing a multidisciplinary team of over 50 professionals. This team spans across key engineering domains, including process engineering, automation, validation, and maintenance, all working in synergy to enhance manufacturing efficiency, ensure product quality, and maintain operational reliability at scale.

As a senior leader, the Director is entrusted with the strategic oversight of all engineering operations, ensuring full alignment with regulatory requirements (such as FDA, EMA, and GMP) while fostering a culture of continuous improvement and innovation. The role plays a pivotal part in shaping the company’s engineering vision, driving technological advancement, and implementing large-scale initiatives that directly support the company’s growth and operational excellence.

This position offers a dynamic and intellectually engaging environment, requiring strong technical acumen, leadership capability, and cross-functional collaboration. It provides a unique opportunity to fully leverage your knowledge, experience, and leadership potential in one of the most impactful areas of manufacturing.

Key Role ‘Objectives:

• Strategic Organization & Alignment: Ensure optimal structure and performance within the engineering division, fully aligned with the broader organizational goals.
• Cost Optimization & Budget Management: Drive efficiency through smart budgeting, cost control, and operational savings initiatives.
• Process Optimization: Lead end-to-end improvements across manufacturing processes to boost productivity and reduce variability.
• Innovation Leadership: Champion the introduction of new technologies and automation solutions to elevate operational capabilities.
• GMP Compliance & Enhancements: Strengthen GMP adherence and introduce sustainable quality improvements.
• Implementation of Large-Scale Improvements: Design and execute scalable engineering initiatives that transform production performance.

Key Responsibilities:

1. 1. Engineering Leadership & Compliance

• Lead engineering teams (process, automation, validation, facilities, maintenance) to ensure compliance with cGMP, FDA, EMA, ICH, and other regulatory requirements.
• Oversee the design, qualification, and maintenance of manufacturing equipment, cleanrooms, and utilities (HVAC, water systems).
• Ensure adherence to 21 CFR Part 11 (electronic records/signatures), Data Integrity (ALCOA+), and ISO standards where applicable.
• Drive risk-based engineering decisions (e.g., FMEA, HAZOP) in collaboration with Quality Assurance (QA) and Regulatory Affairs.

2. Manufacturing Process & Automation

• Optimize pharmaceutical manufacturing processes (solid dosage, biologics, sterile filling, etc.) for efficiency, scalability, and compliance.
• Lead Process Analytical Technology (PAT) and Industry 4.0 initiatives (IoT, AI/ML, digital twins) to improve process control and reduce deviations.
• Oversee automation & control systems (SCADA, PLC, MES) and ensure CSV (Computer System Validation) for manufacturing execution systems.
• Implement continuous improvement (Lean, Six Sigma) methodologies to reduce waste and improve yield.

3. Facility & Equipment Management

• Manage CAPEX projects for new production lines, facility expansions, or tech transfers.
• Ensure proper calibration, preventive maintenance (PM), and reliability engineering to minimize downtime.
• Lead tech transfer activities for new products, including scale-up and process validation (PPQ).
• Collaborate with EHS (Environmental, Health & Safety) to ensure compliance with OSHA, EPA, and industrial hygiene standards.

4. Cross-Functional Collaboration

• Partner with R&D, Quality, and Operations to align engineering strategies with product development and regulatory filings.
• Work with Supply Chain to ensure equipment and raw material availability.
• Support regulatory inspections (FDA, EMA audits) and address findings related to engineering systems.
• Liaise with IT/OT teams to ensure cybersecurity in manufacturing systems (ISA/IEC 62443, GAMP 5).

5. Innovation & Sustainability

• Drive adoption of green engineering practices (energy efficiency, waste reduction).
• Evaluate and implement single-use technologies (for biologics) or continuous manufacturing (vs. batch processing).
• Stay updated on emerging trends (mRNA, cell/gene therapy manufacturing, modular facilities).

Experience Requirements:

• Education: Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Pharmaceutical, or Electrical). Advanced degrees (PhD, MBA) are an asset.
• Proven leadership experience in managing large, multidisciplinary engineering teams within a manufacturing or highly regulated environment, preferably in the pharmaceutical or life sciences sector, heavy industry and automotive industry.
• Strong technical background in process engineering, automation, validation, and equipment maintenance. In-depth knowledge of GMP, FDA/EMA regulations, ISPE guidelines, and ICH Q7/Q9.
• Project Management: Proven track record in driving projects end-to-end, from planning to execution, within budget and compliance parameters.
• Certifications (Preferred): PMP, Six Sigma Black Belt, or ISPE membership.

What the Company Offers:

This is a high-impact strategic leadership role within a rapidly growing manufacturing company that is a recognized leader in its market. The company offers:

• Strategic leadership opportunity with influence over long-term operations and innovation.
• Relocation support package.
• Comprehensive health insurance.
• Stable and growth-oriented environment.

This role is ideal for a proven leader ready to drive large-scale transformation within a regulated, innovation-driven environment.

Only short-listed candidates will be contacted, so – good luck to all of you!

We always properly take care of all applications, and you can be sure that the personal details of every single one of you will be treated with the utmost respect, confidentiality, and full compliance with the Personal Data Protection Law.

Talent Factor holds a license from the National Employment Agency with No. 3647 dated 19.01.2024.