Validation Engineer Technician more… ▼
| Location: | Billerica, MA |
| Company: | pharmalucence |
| First posted: | February 25, 2015 |
Summary
Assists in the validation of process equipment, utilities, systems, and facilities improvements in conjunction with validation program and capital improvement projects
Responsibilities and Tasks
Assists with major engineering challenges pertaining to policies, plans, and objectives
Works with Manufacturing, Facility, Utility, and Quality Control design, detailed design, specification, procurement, construction, and commissioning of process equipment for cGMP production facilities
Drafts/authors validation/qualification protocols and supporting Standard Operating Procedures (SOPs) as required
Provides technical assistance and/or directly support Production, QC, Process Support, and RA/QA groups
Revises procedures as needed to improve compliance and efficiency of manufacturing
Assists in the validations of process equipment, facilities, systems, and utilities
Provides technical support to Development and QC groups on cGMP implementation and validation of manufacturing equipment for new processes
Assists in the validation maintenance program for all process equipment, utilities, systems, and facilities
Supports the validation of new processes for manufacturing, development, and quality control
Assists in making system improvements in conjunction with Manufacturing, Facilities, Quality Assurance, Validation and Regulatory
Validation Support
Assists in the validation maintenance activities to insure compliance and proper maintenance/operation of process equipment utilities, systems, and facilities
Assists in the commissioning of equipment FAT / SAT
Supports engineering standard practices that will result in consistent, reproducible documents
Assists in the development / improvement of Commissioning Guidelines and Templates
Assists in the development and execution of engineering tests, SATs/ Commissioning test plans
Assists in execution validation / re-qualifications protocols (Refrigerators, freezers, sterilizers,depyrogenations ovens, incubators, lyophilizers, and applicable equipment)
Assists in the development of engineering project documentation
Provides project support ensuring generation of all supporting documentation (scope documents; approval slides; work orders; protocols)
Assists in peer review for all QA and Engineering documentation
Provides Operational support for re-qualification of process equipment
Provides equipment operational support
Knowledge Skills and Abilities
Ability to read engineering drawings
Good verbal, written and interpersonal communication skills
Good computer skills
Familiarity with Kaye Validator 2000 a plus
Knowledge of instrumentation and controls background
Must be able to work in a fast-paced, multi-disciplinary environment
Experience in a pharmaceutical cGMP manufacturing or compliance environment preferred
Experience and training on industry standards for aseptic manufacturing engineering requirements preferred
Working Knowledge of cGMP preferred
Knowledge of parenteral manufacturing preferred
Education and Experience
Minimum 2-4 years related experience
Pharmalucence is an Equal Opportunity Employer
Individuals with Disabilities and Protected Veterans are encouraged to apply.
If you need help applying online, please contact jrobbins@pharmalucence.com or call Joyce, HR Assistant at 781-275-7120
Type: Full-time.
To apply, please send your resume to hr@pharmalucence.com or use the ‘apply now’ button below:
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