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Job Description
**Job Summary:**
Meira GTx seeks a skilled Process/Project Engineer to support GMP manufacturing process operations and associated facilities and utilities services in a highly regulated environment.
**Job Description:**
* **Manufacturing Support:** Integration into the relevant business unit to support manufacturing requirements in a highly regulated GMP environment for the manufacture of Advanced Therapeutic Medicinal Products (ATMPs).
* **Capital Projects:** Support the design and review of capital projects, particularly for single-use biopharmaceutical manufacturing equipment.
* **Vendor Coordination:** Coordinate vendor activities for commissioning, qualification, maintenance, calibration, and process improvements.
* **Technical Transfer:** Support technical transfer activities, including design and developing specifications for single-use equipment items.
* **Provide SME input to Process Failure Modes and Effects Analysis (FMEA).**
* **Engineering Standards:** Assist in implementing and developing applicable engineering specifications and standards as they relate to local and multi-site Operations.
* **Safety, Health, and Environment (SH&E):** Provide SME input on SH&E programs, including risk assessments, safety investigations, and other safety improvement activities.
* **GMP and Documentation Compliance:** Ensure all work complies with GMP, Data Integrity, and Good Documentation Practice (GDP).
* **Continuous Improvement:** Demonstrate a right-first-time ethos while ensuring compliance with statutory, regulatory, and company standards, procedures, and systems.
* **Waste Reduction and Energy Efficiency:** Identify and implement technology-based and work practice solutions to reduce waste and overall cost.
**Key Performance Indicators:**
* Deliver sustainable improvements measured by KPIs aligned with safety and quality compliance policies.
* Support project deliverables, ensuring on-time completion and adherence to quality standards.
* Proactively contribute to the development and effectiveness of the engineering team.
**Key Job Competencies:**
* Comprehensive practical and theoretical background in a wide range of biopharmaceutical equipment and manufacturing processes.
* Familiarity with computerized equipment systems and data integrity principles.
* Experience with commissioning and qualification of process equipment and utilities.
* Strong problem-solving skills and the ability to resolve issues in a structured and timely manner.
* Leadership qualities with the ability to inspire and motivate others.
* High motivation with the ability to set and achieve challenging goals.
* Excellent planning and organizing skills with efficient time management.
* Professional demeanor with the ability to handle pressure and treat others with respect.
* Innovative thinking and creativity to meet challenges resourcefully.
* Effective communication skills, both verbal and written, with good presentation abilities.
**About Meira GTx:**
Meira GTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development, including three ocular indications, a salivary gland condition, and a Parkinson's disease program. Our initial focus on diseases of the eye, salivary gland, and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas.