Position Overview:
We are looking for a highly skilled and experienced Senior Automation Engineer to join our pharmaceutical manufacturing facility. The ideal candidate will be responsible for leading automation projects, ensuring compliance with computer system validation standards, investigating system issues, and documenting detailed deviation reports. This role requires a deep understanding of automation technologies and a strong commitment to maintaining the highest standards of quality and compliance in a regulated environment.
Key Responsibilities:
- Take charge of automation projects, from start to finish, including planning, implementation, and validation. You will play a key role in developing and implementing creative solutions that will redefine our manufacturing processes.
- Develop and implement computer system validation (CSV) protocols and ensure compliance with regulatory requirements. Your meticulous attention to detail will ensure that our systems are flawless and meet all industry standards.
- Investigate and address automation system issues, promptly resolving them to maintain uninterrupted operations and minimize downtime.
- Write comprehensive deviation reports, including root cause analysis and corrective actions. Your analytical skills will enable you to identify the underlying cause of any deviations and implement effective solutions.
- Work closely with various teams to ensure successful project delivery and system integration. Your ability to collaborate effectively with different teams will be crucial in achieving the seamless integration of automation systems.
- Provide technical support and guidance to junior engineers and other team members.
- Keep up-to-date with industry trends, regulatory changes, and advancements in automation for pharmaceutical manufacturing. Your commitment to staying informed will help us maintain our world-class standards and a competitive edge.
Qualifications:
- Educational requirements: A Bachelor's degree in Engineering, Computer Science, or a related field, or equivalent experience. A Master's degree is preferred.
- Minimum of 5-7 years of experience in automation engineering within the pharmaceutical industry.
- Demonstrated expertise in successfully leading and implementing automation projects.
- Strong knowledge of computer system validation (CSV) and regulatory requirements (e.g., FDA, GxP).
- Strong ability to identify and resolve issues effectively.
- Experience in writing detailed deviation reports, including root cause analysis and corrective actions.
- Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
- Proficiency in automation software and tools used in pharmaceutical manufacturing.
Preferred Skills:
- Familiarity with Good Manufacturing Practices (GMP) and Good Automated Manufacturing Practice (GAMP).
- Experience with PLCs, SCADA systems, and HMI programming.
- Knowledge of pharmaceutical manufacturing processes and equipment.
