- 3 - 5 years of experience in a Process or Equipment engineering role, preferably in the pharmaceutical drug products manufacturing industry.
- Ability to read and understand engineering drawings such as P&IDs, equipment/facility layout drawings, electrical/pneumatic drawings, and functional specifications.
- Thorough understanding of cGMP and FDA requirements
- Strong communication and documentation skills
- Proven project management skills
- Experience with equipment qualification following ISPE and ASTM guidelines.
- Proficient with Microsoft Office Suite, Maximo, Calibration program software, MES, etc.
- Preferred Qualifications:
- Prior experience as an equipment or process engineer with process control systems and troubleshooting of pharmaceutical manufacturing processes and packaging equipment.
- Familiarity with Sterile F/F equipment qualification is a plus.
- Familiarity with the IOQ/PQ process/packaging equipment for the pharmaceutical industry.
- Familiarity with Maximo or equivalent Regulatory Asset Manager software.
Experience / Education:
- Bachelor’s degree in engineering (Mechanical, Electrical, Industrial) or a related field.
- 5+ years of maintenance experience in a pharmaceutical, biotechnology, life science, or FDA-regulated manufacturing environment.
Knowledge / Skills / Abilities:
- Technical: Strong understanding of engineering principles, process design and optimization, quality control, pharmaceutical manufacturing technologies, equipment, and relevant software. Knowledge of cGMP guidelines and regulatory compliance is essential.
- Analytical & Problem-Solving: Ability to analyze complex processes and data, identify bottlenecks, troubleshoot issues, and develop effective solutions.
- Soft Skills: Excellent communication (written and verbal), teamwork, leadership, project management, organizational abilities, time management, adaptability, attention to detail, critical thinking, and negotiation skills.
Industry Specific: Familiarity with FDA regulations, cGMP guidelines, Lean Manufacturing, and risk assessment techniques (HAZOP, FMEA).
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.