Project Engineer, Manufacturing Engineer

Role Summary

The Project Engineer at our pharmaceutical manufacturing site will be responsible for planning, executing, and overseeing engineering projects to enhance the facility's efficiency, productivity, and compliance with regulatory standards. This role involves collaboration with various departments, including production, quality, and maintenance, to ensure the successful implementation of projects within budget and timeline constraints. The Project Engineer will utilize their technical expertise to solve complex problems, innovate processes, and support the continuous improvement of manufacturing operations.

• Develop detailed project plans, including scope, objectives, timeline, and budget.
• Coordinate and manage engineering projects from conception to completion, ensuring they meet the defined goals.
• Conduct feasibility studies and risk assessments for proposed projects.

• Provide technical support and expertise in the design, installation, and commissioning of equipment and systems.
• Develop engineering solutions to improve manufacturing processes, reduce costs, and enhance product quality.
• Ensure all engineering activities comply with GMP, FDA, and other regulatory standards.

• Work closely with production, quality assurance, maintenance, and other departments to ensure project alignment with operational needs.
• Facilitate effective communication among project stakeholders, providing regular updates on project status and progress.
• Lead or participate in cross-functional teams to support continuous improvement initiatives.

• Prepare and maintain detailed project documentation, including plans, reports, and records.
• Ensure all project activities are properly documented and comply with regulatory and company standards.
• Conduct regular audits and inspections to ensure compliance with engineering standards and regulations.

• Develop and manage project budgets, ensuring cost-effective use of resources.
• Monitor project expenditures and identify opportunities for cost savings.
• Coordinate with vendors and suppliers to procure necessary materials and services.

• Identify and resolve technical issues that arise during project implementation.
• Conduct root cause analysis of engineering problems and develop corrective actions.
• Utilize innovative thinking to overcome project challenges and achieve desired outcomes.

Note: Please note that this job description is not exhaustive and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

ACCOUNTABILITY/EXECUTION – A willingness to accept responsibility or to account for one’s actions. Accountability is when an individual or a department experiences consequences for their performance or actions.

FOSTERING COLLABORATION/TEAMWORK – The ability to work jointly with others, demonstrate interest, skill, and success in getting groups to learn to work together, and build partnerships for global performance. Respects others.

INITIATIVE – Identifying what needs to be done and doing it before being asked or before the situation requires it.

INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern to be perceived as responsible, reliable, and trustworthy.

PROBLEM-SOLVING – The ability to find solutions to complex problems quickly; good analytical skills.

COMPLEXITY/STRESS MANAGEMENT / TIME MANAGEMENT – The ability to function under pressure, maintain self-control, focus on core issues, and manage time and resources effectively.

Education
:

• Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or related field).
• Relevant certifications (e.g., PMP) are a plus.

Experience
:

• Minimum of 3-5 years of engineering experience in a pharmaceutical or manufacturing environment.
• Proven track record of managing and executing engineering projects.

Skills
:

• Strong knowledge of GMP, FDA…