Process Excellence Engineer

As a Process Excellence Engineer at Piramal Pharma Solutions, your core responsibilities include collaborating across departments to generate and update master production records, handling deviations, and leading investigations for continuous improvement. You'll also analyze production data, engage with external clients, and ensure compliance with regulatory standards. With a focus on enhancing process performance, you'll facilitate the development of technical solutions and actively contribute to Operational Excellence initiatives.

To qualify as a Process Excellence Engineer at Piramal Pharma Solutions, candidates should possess at least a Bachelor’s Degree in Chemistry or Engineering, although a Master’s or Ph.D. is preferred for those with less experience. Additional skills include strong project management abilities, effective communication, and confidence in handling internal and external stakeholder relationships, all of which are essential for success in this position.

A Process Excellence Engineer plays a vital role in ensuring compliance at Piramal Pharma Solutions by adhering to all applicable regulations, such as 21 CFR Parts 210/211 and ICH Q7. You'll recognize sources of potential failure and enhance documentation practices to minimize errors. Your efforts in working with Operations Personnel will help improve compliance and safety protocols within the manufacturing environment.

At Piramal Pharma Solutions, a Process Excellence Engineer works in a fast-paced pharmaceutical manufacturing environment. This role often involves hands-on interaction with equipment and production processes, emphasizing safety and compliance with industry standards. Given the nature of this work, you might encounter potential exposure to hazardous materials, necessitating adherence to safety protocols and usage of personal protective equipment.

Piramal Pharma Solutions is committed to fostering growth for its Process Excellence Engineers. Opportunities for career advancement include specialization in project management, moving into higher technical roles, or assuming leadership positions within the engineering or operations teams. Furthermore, participation in continuous improvement projects and training programs can enhance your skill set, preparing you for future challenges in the pharmaceutical industry.

When asked about your experience with master production records, highlight specific instances where you've developed, revised, or approved these documents. Discuss your attention to detail and how you ensure compliance with regulatory standards, showcasing your ability to work collaboratively with different departments.

In responding to how you manage deviations, emphasize your problem-solving skills and methodical approach. Provide examples of investigations you’ve led, documenting your process for identifying root causes and implementing corrective actions, which are essential for maintaining compliance and quality.

Discuss specific methodologies you apply for process improvement, such as Lean or Six Sigma, and outline any successful projects. Share how you foster collaboration among teams to drive operational excellence, citing concrete metrics that illustrate the improvements achieved.

In your answer, communicate your thorough understanding of GMP regulations and cite examples of how you've applied these standards in previous roles. Discuss any audits or compliance checks you've managed and the steps you've taken to adhere to safety protocols.

Provide insights into your time management and prioritization skills when handling multiple projects. Talk about a specific situation where you've successfully balanced conflicting priorities, detailing how you communicated with stakeholders to align expectations.

When discussing a successful project, focus on the objectives, your role, and the outcomes achieved. Highlight how you applied leadership skills and drove teamwork to achieve results that aligned with the organization’s goals.

Mention specific tools and software you regularly use for data analysis, such as Excel, SQL, or manufacturing intelligence software. Emphasize how you've employed these tools to interpret production data and recommend actionable insights to improve process efficacy.

Effective communication is crucial in ensuring project success. Discuss your approach to facilitating clear communication, such as regular meetings, updates, and collaborative platforms, and explain how this fosters a productive work environment and prevents misunderstandings.

To address this question, share insights on best practices in operational excellence, outlining any innovative ideas you believe could enhance efficiency. Discuss how engagement from all levels of the workforce is essential for successfully rolling out new initiatives in an organization.

Here, you should convey your enthusiasm for the mission and values of Piramal Pharma Solutions. Talk about how you align with their commitment to quality and continuous improvement, and express your desire to contribute your skills towards innovative pharmaceutical solutions that positively impact patient care.