Job Description
Job Purpose
The Mechanical Engineer is responsible for assessing project requirements. Measuring the performance of mechanical components, devices, and engines.
Responsibilities
- Lead the design and development of mechanical components and systems for pharmaceutical equipment, from concept to production.
- Conduct engineering analyses, including structural, thermal, and fluid dynamics simulations, to optimize performance and ensure compliance with industry standards and regulations.
- Collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure seamless integration of mechanical systems into final products.
- Drive continuous improvement initiatives to enhance product reliability, manufacturability, and cost-effectiveness.
- Support product testing, validation, and troubleshooting activities.
- Stay abreast of emerging technologies, industry trends, and regulatory requirements relevant to pharmaceutical equipment design and manufacturing.
Requirements
- Bachelor’s Degree in Mechanical Engineering or related field; advanced degree preferred.
- Minimum of 5 years of experience in mechanical engineering roles within the pharmaceutical industry.
- Strong understanding of regulatory requirements, such as FDA cGMP, ISO 13485, and ASME BPE, relevant to pharmaceutical equipment design and manufacturing.
- Thorough understanding of dosage administration and measurement, chemical compounds, medical brands, etc.
- Outstanding knowledge of MS Office and Pharmacy information systems
- Good organizing skills.
- Excellent problem-solving skills and the ability to apply engineering principles to develop innovative solutions.
- Effective communication skills, with the ability to collaborate effectively with internal teams and external stakeholders.
- Proven track record of delivering high-quality, compliant, and commercially successful products on schedule and within budget.
- Ability to manage multiple projects simultaneously and prioritize tasks effectively.J