Engineering excellence is key to our operations. We are seeking a highly skilled Process Development Specialist to join our team.
* The ideal candidate will be responsible for ensuring that engineering records meet regulatory requirements and standards of good practice.
* This involves coordinating with design consultants and other departments to develop and implement process designs and equipment layouts.
* Review and approval of detailed designs from vendors are also a crucial part of the role.
* The successful candidate will ensure project execution work is completed on time and in accordance with company policies.
* Effective communication and collaboration with colleagues are essential for efficient performance and improvement.
* Responsibilities include preparing, reviewing, and updating standard operating procedures to meet cGMP requirements.
* The specialist will ensure compliance with current Good Manufacturing Practices (cGMP) for all process and manufacturing equipment.
* Preventive maintenance schedules will be developed in coordination with relevant departments to minimize downtime and ensure efficient operation.
* The Process Development Specialist will be responsible for the development, execution, and review of qualification/re-qualification and validation activities for related processes and equipment.
* This includes ensuring Engineering Department activities align with Quality Management Systems.
* The specialist will regularly review and verify Engineering department standard operating procedures to meet cGMP and regulatory requirements.
* Functional testing, site acceptance testing, and installation qualification activities will be carried out as required for new equipment or systems.
* Operational qualification activities will also be performed to ensure equipment is functioning as expected.
* Certification and calibration of relevant instruments will be performed according to validation requirements and documented as per cGMP standards.
* All engineering changes will be assessed and implemented in accordance with cGMP and local SOPs.