16 Validation Engineer Jobs in Summit, NJ
Sorry! This job is no longer available. Please explore similar jobs listed on the left.
Synectics Inc. is Hiring a Validation Engineer Near Summit, NJ
- Implementation of manufacturing and laboratory equipment, and computerized systems at multi-use sites
- Capable of taking Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.
- The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment, and computerized systems at multi-use sites through interaction with internal customers and external service providers.
- The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation.
- With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope.
- As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
- Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
- Develops protocols, and associated reports while adhering to a change management process.
- Supports the execution of equipment qualifications and validation protocols.
- Supervises vendors for qualification functions.
- Supports calibration, equipment qualification and validation activities.
- Configures and documents the configuration of computerized systems.
- Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.
- Manages projects of varying scope and complexity.
- Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
- Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.
- Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
- Completes all qualification and validation documentation with accuracy, completeness, and compliance to Company standards.
- Provides excellent customer service and support.
- Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
- Provides technical support and guidance on calibration and equipment qualification issues.
- Interfaces with customers to ensure all expectations are being met.
- Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
- Environment may include working in office or in a laboratory / manufacturing area.
- Required BS degree in Engineering / Computer Science
- Minimum 5 years of experience in FDA-regulated industry, with min 3 years' experience in CSV
- Strong working knowledge of MS Windows client and server technologies.
- Working knowledge of standard networking principles and technologies.
- Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.
- Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.
- Ability to work with the end user to identify and document User and Functional Requirements.
- Knowledge of pharmaceutical laboratory and manufacturing systems.
- Experience executing equipment qualification documents.
- Ability to interact effectively with laboratory, QA, and Facilities groups.
- Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
- Ability to effectively manage multiple tasks and activities simultaneously.
- Strong written and verbal communication skills along solid presentation skills.
- Proficient at writing well-formulated emails and reports.
- Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
- Ability to effectively communicate with employees, contractors, and vendors.
- Experience with technical writing and document development / generation.
- Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
- Ability to work safely when working alone or working with others.
- Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.
- Technical / Professional Knowledge
- Problem Solving / Troubleshooting
- Action Oriented
- Attention to Detail
- Multi-tasking
- Building Relationships
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
Job Summary
Contractor
Wholesale
$71k-87k (estimate)
07/14/2024
08/10/2024
synectics.net
LEBANON, OH
25 - 50
1993
HEIDI BALE
<$5M
Wholesale
Related Companies
About Synectics Inc.
Environmental Synectics, Inc. (Synectics) is a HUBZone certified small business enterprise with more than 25 years of experience providing environmental services, information technology services and advisory & assistance services to federal government agencies as well as commercial and Fortune 500 companies. Since our founding in 1993, we have successfully executed work for the U.S. Air Force, Army and Navy at scores of installations nationwide. Synectics architected and implemented the environmental industrys most versatile cloud-based data management system with integrated Automated Data Rev...iew (ADR) capabilities. Our Environmental Data Management System (EDMS) requires only a secure internet connection to allow project teams around the globe access to datasets, report generation capabilities, and communication with colleagues. Synectics EDMS provides comprehensive functionality to all environmental projects and is backed by a team of professionals committed to leveraging innovative technologies to optimize processes, reduce costs and shorten schedules for the benefit of our clients.
More
Show less
The job skills required for Validation Engineer include Problem Solving, Calibration, Troubleshooting, Microsoft Office, Networking, Customer Service, etc. Having related job skills and expertise will give you an advantage when applying to be a Validation Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Validation Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Validation Engineer positions, which can be used as a reference in future career path planning. As a Validation Engineer, it can be promoted into senior positions as a Validation Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Validation Engineer. You can explore the career advancement for a Validation Engineer below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
