his position will be responsible for the advance engineering technical support to the assigned manufacturing / product line includinging functioning as the Subject Matter Expert (SME) for the line, processes optimization, day to day technical support to maintenance and operations teams, quality investigations related to the equipment and systems, optimization projects scope’s development and/or execution. Responsible for managing and resolving medium to high complex problems by engineering advance principles, good engineering practices, advance technologies and Root Cause Investigation (RCA) tools. Leads and / or performs troubleshooting and modifications to the automated equipment adhering to Pharmaceutical and Medical Devices GMP change control standards and policies. Responsible for the reliability of line efficiency and support of the maintenance program following company procedures and good maintenance practices.
Responsibilities: Essential Duties
- Analyzes existing equipment, processes, facilities, infrastructure and systems to identify areas of improvement and recommend solutions to optimize performance.
- Acts as a Subject Matter Expert for designated systems/ technologies and provide technical recommendations
- Anticipate potential process related problems, risks and technical conflicts and develop the necessary contingency plans to improve business continuity.
- Performs troubleshooting and modifications to the automated equipment adhering to Pharmaceutical and Medical Devices GMP change control standards and policies.
- Creates and modifies system specifications and standard operating procedures for the systems supported.
- Trains users and peers on systems.
- Supports software life cycle efforts.
- Contributes to development of continuous improvement to systems.
- Documentation, testing, commissioning and validation support following GDP.
- Provides project implementation support.
- Performs administrative, upgrades and maintenance tasks for equipment/ control systems.
- Supervises consultants and .
- Ability to manage medium complex projects without assistance.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.
Expertise: Knowledge & Skills
- Requires breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.
- Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.
- Judgement is required in resolving complex problems based on experience.
- Interacts with and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.
- 3-5 years of engineering design experience.
- Previous experience and/or exposure with highly automated manufacturing equipment including sseptic Filling, iIsolators and packing equipment.
- Advance engineering problem solving skills and experience.
Expertise: Qualifications -Education/Experience/Training/Etc
- Bachelor's degree required.
- 10-12 years related experience required.
- Regular and predictable attendance
- Occasional business travel required, Valid driver's license and passport