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Engineering - Validation Engineer

Mindlance

Devens, MA

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JOB DETAILS
SKILLS
Asset Management, Biology, Change Control, Chemistry, Code of Federal Regulations, Communication Skills, Computer Systems, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Quality, Disaster Recovery, Document Control, Equipment Validation, GMP (Good Manufacturing Practices), Identify Issues, Laboratory, Preventative Maintenance, Problem Solving Skills, Purchasing/Procurement, Quality Control, Quality Management, Regulations, Regulatory Requirements, Requirements Management, Risk Analysis, Root Cause Analysis, Scripting (Scripting Languages), Software Debugging, Software Testing, Standard Operating Procedures (SOP), System Validation, Team Player, Test Scripts, Validation Plan, Writing Skills
LOCATION
Devens, MA
POSTED
13 days ago
Engineering - Validation Engineer
Deven, MA
100% onsite with some flexibility
Work Schedule: Mon-Fri(normal business hours)

Responsibilities will include (but not limited to):
- Manage the entire lifecycle of QC laboratory instruments from procurement to qualification to decommissioning, ensuring all activities are in compliance with applicable policies/regulations.
- Design, execute, manage, and implement QC instrument/software qualification documents such as (but not limited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ protocols, software test scripts, configuration specifications, risk assessments, qualification summary reports
- Author/execute computer system validation scripts using an electronic validation database (ALM), or paper-based
- Own change controls specific to the qualification of QC instruments and its associated software
- Update the asset management database to reflect new assets, calibrations, preventative maintenances
- Author instrument operational SOPs as needed
- Coordinate/interface/host vendors on site
- Champions qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive Actions (CA/Client)
- Acts as the liaison between Digital Plant (IT) and lab departments
- Execute periodic assessments/decommissioning, as needed

Qualifications and Experience Required:
- Required Bachelor s degree or Master s degree in Engineering, Chemistry, Biology, or in a related, scientific/computer-based field.
- Minimum of 2 4+ years experience in the biopharmaceutical industry or equivalent combination of education and validation/lab experience will be considered.
- Quality management system experience including: document control/management, change controls, investigations, deviations, electronic validation databases, asset management database
- Knowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP, electronic record/electronic signature, data integrity, disaster recovery
- Incumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects
- Demonstrated success in cross functional influencing, strong communication, and collaboration skills
- Must have GMP experience
- Microsoft Office Applications, preferred.
- Computer system validation experience, preferred
- Equipment validation experience is a plus

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.

About the Company

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Mindlance