We are seeking a dynamic and experienced Technical Operations and Process Optimization Manager to play a crucial role in driving operational excellence and engineering compliance within our organization.
In this role, you will lead initiatives across validation, process engineering, sterility assurance, asset reliability, and engineering compliance to ensure the highest standards of quality, efficiency, and regulatory compliance are met.
As a Technical Operations and Process Optimization Manager, you will be responsible for the management of the Technical Operations & Optimization team within the Engineering Department in line with routine operational and longer-term strategic plans.
Validation Management: Developing and executing validation comprehensive strategies and protocols for processes, equipment, and systems, ensuring compliance with regulatory requirements and industry best practices. Coordinating validation activities, including protocol development, execution, and documentation, to support product manufacturing and quality assurance activities.
Process Engineering: Leading cross-functional teams in identifying, analyzing, and optimizing operational processes to enhance efficiency, productivity, and cost-effectiveness. Utilizing tools such as process mapping, data analysis, and root cause analysis to drive continuous improvement initiatives and streamline workflows.
Sterility Assurance: Establishing and maintaining robust sterility assurance programs to safeguard product integrity and patient safety in sterile manufacturing environments. Implementing procedures for monitoring and controlling microbial contamination risks, including environmental monitoring, aseptic processing controls, and sterilization validation.
Asset Reliability: Developing and implementing asset reliability strategies to maximize equipment uptime, minimize unplanned downtime, and optimize asset performance across manufacturing facilities. Utilizing reliability engineering principles, predictive maintenance techniques, and condition monitoring technologies to proactively manage equipment reliability and mitigate risks of equipment failure.
Engineering Compliance: Supporting the development and adherence to global and local engineering equipment standards, regulatory requirements, and quality management systems to maintain compliance with relevant regulations and standards. Collaborating with regulatory affairs and quality assurance teams to interpret and implement regulatory guidelines, standards, and directives related to validation, process engineering, and equipment compliance.
Continuous Improvement: driving a culture of continuous improvement by fostering innovation, encouraging employee engagement, and championing process optimization initiatives. Lead or support Lean Six Sigma projects, Kaizen events, and other improvement activities to drive measurable results and enhance operational performance.
Cross-functional Collaboration: collaborating closely with local and global cross-functional teams, including manufacturing, quality assurance, regulatory affairs, supply chain, and R&D, to align operational activities with business objectives and ensure seamless execution of projects and initiatives. Serve as a subject matter expert and provide guidance on technical operations and process optimization matters.
Risk Management: Identifying, assessing, and mitigating operational risks associated with validation, process engineering, sterility assurance, asset reliability, and engineering compliance. Develop risk management strategies and mitigation plans to proactively address potential threats to product quality, patient safety, and regulatory compliance.
Compliance: responsibility for emergency procedures, safety systems, safety performance, communication, and behaviors within the department. Playing a leadership role in health, safety and environmental issues and teams. Leading Engineering CAPA investigations, determining accurate root cause and implementing action plans to prevent reoccurrences. Ensuring all Quality Track Wise actions that are assigned to the group are actioned and closed in a satisfactory manner. Ensuring 5S standards are maintained and improved. Ensuring the asset reliability developed and maintenance in alignment with ISO standards.
Bachelor’s degree in engineering, science or a related field; advanced degree preferred.
Proven experience in technical operations, process optimization, and compliance management within the pharmaceutical, biotechnology, or medical device industry.
Strong understanding of regulatory requirements, including FDA, EMA, and other relevant authorities, pertaining to validation, process engineering, and sterility assurance.
Experience with risk-based approaches to validation and process optimization, including FMEA and statistical analysis.
Demonstrated people leadership skills with the ability to lead cross-functional teams and drive initiatives to successful completion.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels of the organization.
Strong analytical and problem-solving abilities, with a focus on data-driven decision-making.
Proven track record of implementing process improvements and driving operational excellence initiatives.
Knowledge of asset reliability principles, including predictive maintenance strategies, is desirable.
Certification in relevant areas such as Six Sigma, Lean Manufacturing, or Project Management is a plus.
Patient-centric leadership with a strong commitment to quality, safety, and operational excellence.
Results-oriented mindset with the ability to drive initiatives and deliver measurable business outcomes.
Strong customer focus and the ability to build effective partnerships with internal and external stakeholders.
Excellent leadership, coaching, and mentoring skills, fostering high-performing and engaged teams.
Strong influencing and stakeholder management skills, with the ability to navigate complex organizational environments.
Excellent communication and interpersonal skills, enabling effective collaboration across functions and levels.
High level of initiative, accountability, and ownership in driving continuous improvement.
Strong systems-thinking approach with the ability to understand and optimize complex processes.
Demonstrated resilience, adaptability, and ability to lead through change.
Strong work ethic, self-motivation, and genuine interest in developing people and organizational capabilities.
