About the Role:

As a Project Engineer specializing in Pharmaceutical Engineering within the manufacturing sector, you will play a critical role in supporting the design, development, and commissioning of pharmaceutical manufacturing processes and equipment. Your primary objective will be to ensure that all engineering solutions meet regulatory standards and operational efficiency requirements, facilitating the successful production of high-quality pharmaceutical products. You will collaborate closely with cross-functional teams including quality assurance, production, and project management to implement best practices and troubleshoot technical challenges. This role demands a proactive approach to commissioning activities, ensuring that new systems and equipment are validated and fully operational according to project timelines. Ultimately, your contributions will help optimize manufacturing workflows, enhance compliance, and support the company's commitment to delivering safe and effective pharmaceutical products to market.

Minimum Qualifications:

• Bachelor's degree in Pharmaceutical Engineering, Chemical Engineering, or a related engineering discipline.
• Demonstrated experience in pharmaceutical manufacturing environments, specifically in commissioning and validation activities.
• Strong understanding of regulatory requirements such as FDA, cGMP, and other relevant industry standards.
• Proficiency in interpreting engineering drawings, specifications, and technical documentation.
• Excellent communication and teamwork skills to effectively collaborate with multidisciplinary teams.

Preferred Qualifications:

• Advanced degree or certifications related to pharmaceutical engineering or manufacturing.
• Experience with automation systems and control technologies used in pharmaceutical production.
• Familiarity with project management methodologies and tools.
• Knowledge of risk management and quality assurance processes within pharmaceutical manufacturing.
• Previous consulting experience in a pharmaceutical or biotech environment.

Responsibilities:

• Lead and support commissioning activities for pharmaceutical manufacturing equipment and systems, ensuring compliance with industry regulations and company standards.
• Collaborate with engineering, quality, and production teams to develop and implement process improvements and validation protocols.
• Conduct technical assessments and provide recommendations to optimize manufacturing processes and equipment performance.
• Prepare and review technical documentation, including commissioning plans, validation reports, and standard operating procedures.
• Assist in troubleshooting and resolving engineering issues during commissioning and initial production phases.

Skills:

The required skills in Pharmaceutical Engineering and Commissioning are essential for daily tasks such as designing and validating manufacturing processes, ensuring equipment meets operational and regulatory standards, and leading commissioning activities. These skills enable the consultant to analyze complex engineering challenges and implement effective solutions that enhance production efficiency and compliance. Preferred skills, including familiarity with automation and project management, complement the core competencies by allowing the consultant to manage projects more effectively and integrate advanced technologies into manufacturing workflows. Strong communication and documentation skills are used daily to coordinate with various teams and maintain clear, accurate records of commissioning and validation activities. Together, these skills ensure the consultant can deliver high-quality engineering support that aligns with organizational goals and regulatory expectations.