Lead prepare coordinate monitor and manage the implementation of assigned engineering projects.
Develop equipment/system specifications identify infrastructure requirements and perform capability assessments as required for each project.
Review markup and ensure project documents such as specifications submittals RFIs test documents drawings and/or other project specific documents are created and documented accurately.
Responsible for the generation of the change controls associated with the assigned projects conforming with industry standards quality and regulatory expectations.
Work with outside contracting firms to bring projects from the conceptual design stage to implementation and provide solutions to technical problems that may arise during the life of the project.
Coordinate project activities with A&E designers General Contractors and vendors.
Inspect field progress of building construction equipment/systems modifications and/or improvements
Establish the methods by which all field tests are administered and monitor the quality of those tests.
Actively review projects status and communicate progress and constraints.
Track and ensure completion of project punch list items.
Liaison with CAPEX team for the implementation of capital projects.
Support new product introductions (NPIs).
Oversee contractors during projects implementation as required.
Works with QA/QC to ensure proper testing inspection and release after completion of project implementation.
Support equipment IQ/OQ/PQ or any other validation/commissioning startup activity as required.
Ensure new equipment operates in compliance with required EHS regulations and codes.
Develop write edit and/or review in collaboration with Facilities SOPs P&IDs and maintenance procedures for new equipment and/or systems.
Communicate efficiently with Contractors Suppliers OEM providers as well as internal equipment owners and operators for a successful operation of the FDBT facility.
Able to work with other contractors manufacturing validations and quality control personnel regarding changes or improvements to the systems.
Ensure compliance as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines within the areas of responsibility and document out of specification conditions with deviations CAPAs and Change Controls as appropriate.
Continuously stay current with assigned SOPs and keep up to date training file ensuring compliance with all applicable Standard Operating Procedures.
Ensure a safe work environment is maintained through adherence and compliance with safety guidelines policies site procedures and job performance qualifications.
Demonstrate continuous personal pursuit to increasing job knowledge proficiency in technical understanding and problem-solving abilities.
Maintain a positive professional and customer-oriented attitude.
All other duties as assigned.
Technical Expertise: Providing engineering and troubleshooting support develop and present feasible solutions.
Problem Identification and Solution Development: Spotting engineering issues and crafting solutions.
Project Management: Leading installations and projects improvements.
Project Execution: Knowledge and understanding using P&IDs equipment manuals specifications SOPs and be able to use proper judgment when implementing projects.
Equipment Expertise: Select and specify equipment types and specifications and ensure it operates in compliance with regulations and codes.
Collaborative/Coordination Skills: Working cross-functionally with teams like CAPEX and QA/QC. Coordinate execution of projects improvements and other engineering activities.
Communication: Strong written and verbal communications skills with the ability to effectively communicate within cross-functional teams and upper management.
Validation and Compliance: Assisting in equipment validation activities and adhering to environmental health and safety guidelines.
Documentation and Procedures: Crafting URS SOPs P&IDs and maintenance protocols. using the OEM manual and system knowledge.
Effective Communication: Coordinating with diverse stakeholders effectively including presenting technical overviews such as FDA OSHA EH&S EPA and state of Texas requirements.
Regulatory and Industry Knowledge: Understanding regulatory requirements and pharmaceutical manufacturing guidelines including bio-medical bio-technical equipment both upstream and downstream is highly desirable.
Continuous Improvement and Learning: Keeping up-to-update with SOPs and enhancing technical and problem-solving skills.
Leadership and Professionalism: Demonstrating leadership maintaining a positive approach and managing multiple priorities efficiently.
Results Orientation: Being goal-focused with strong analytical and risk management abilities.
Software Proficiency: Proficient in project management software and MS Office.
Adaptability and Self-motivation: Thriving in a fast-paced environment learning swiftly and working independently.
Safety: A focus on safety and compliance with regulations at the forefront of all activities.
All other duties as assigned.
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