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Engineer, GMP Services

Vertex

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Location: Cambridge, MA Posted Date: 4/25/2013 Position Type: Job Code: 3517323BIOS Salary: Competitive Required Education: Bachelors Degree Areas of Expertise Desired: Operations

Description


The Engineer, GMP Services will be part of the Engineering Services team. Works under only general direction to independently determine and develop approaches to solutions.   Provides technical solutions to a wide range of difficult problems.   Solutions are imaginative, thorough, practicable, and consistent with organizational objectives.
Key Responsibilities
Commissioning & Qualification
- Complete understanding and wide application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI .   General knowledge of other related disciplines.
- To prepare effective equipment standards and specifications.
- Maintain an up-to-date knowledge of GEP, commissioning and validation requirements, practices, and procedures
- Preparation and execution of URS, FAT, SAT, commissioning and IQ/OQ/PQ of automated systems, facility systems and pharmaceutical processing equipment
- Write commissioning & validation plans related to specific projects and multi-site procedures.
- Work with commissioning & validation and metrology contractors when required
- Interact with quality, laboratories, manufacturing and facilities departments to facilitate protocol execution as necessary
- Perform Start-up activities
- Perform commissioning and validation activities described in commissioning and validation protocols including thermal studies, cleaning, methods, equipment and utilities validation
- Support implementation of validated system change requests and resolution of deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval
- Identify, generate and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations in a cGMP environment.

Good Engineering Practice (GEP)
- Support development and implementation of Good Engineering Practice (GEP) program
Write GEP program documents
- Support Engineering capital projects
- Apply GMP principles within the workplace. Incorporate cGMP and regulatory compliance into all assigned project scopes, design and construction activities.
- Able to read P&ID, Isometric and 'As Built' drawings
- To comply with site health, safety and environmental policy and with the site standards for work wear and conduct while actively supporting GMP requirements.
- To ensure that GMP, Quality, Health & Safety are considered in all aspects of role and that of team.
- Develops, implements and maintains programs and processes to ensure high quality of operations, office planning, equipment maintenance, and compliance with local building codes as well as, Current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLPs).

Automation:
- Engineer and manage Building & Process control system/equipment improvement, optimization, expansion and upgrade projects to meet site objectives.   Engineer and manage new Building & - Process control/automation projects from the concept to commissioning and validation.
- Complete understanding and wide application of technical principles, theories, and concepts in the field, GMP, GAMP, ISO/ANSI .   General knowledge of other related disciplines.
- Provide moderate to advance technical assistance to site operating groups through investigations, control system assessments, and design support.
- Assist in preparation and execution of the Commissioning & Validation protocols related to automated and control systems.   Provides technical and non-technical feedback to validation personnel for the successful qualification of systems.
- Help to troubleshoot and diagnose Control system complex problems, working closely with manufacturing operators and maintenance personnel.
- Update and develop User Requirement Specifications, Functional Specifications, Design Specifications, Operation and Maintenance Manuals for the new and existing control systems.
 
 
- Bachelors' degree in Engineering, Science or Technical Field
- 5-7 years' experience in engineering field
 
Preferred Qualifications
- Ability to communicate effectively with supervisor and other departments' workload, priorities, and issues to maintain validation schedule
- Assist and direct vendors and contractors as required on equipment within area of responsibility.
- Project management and planning skills.
- Equipment / process design and troubleshooting.  
- Data analysis and interpretation skills.  
- Strong organizational and communication skills.  
- Ability to create, develop and lead a cross-functional team.  
- Creative problem solving skills.  
- Excellent written and oral communication skills.
- PC literacy (Word, Project, Excel, PowerPoint, AutoCAD, Visio, etc).
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified  individuals with known disabilities, in accordance with applicable law.

Requirements

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