Validation Engineer
1 week ago
On-Board Services is hiring a Validation Engineer in Warren, NJ
For immediate consideration please send your resume to
Subject Line: Position Title and State you are Located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Position Type: Full Time / Contract (12 months)
Job Location: Warren, NJ (100% On-Site, Local Candidates Only)
Benefits: Health Insurance (Medical, Dental, Vision), Life Insurance, 401k
Compensation: $50 - $55 per hour
Overview/Summary:
1. PURPOSE AND SCOPE OF POSITION:
The Validation Engineer supports the successful implementation of laboratory equipment and 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 facility, utility, and equipment qualification. With minimum supervision and given general instructions, this individual independently 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.
2. REQUIRED COMPETENCIES:
Knowledge, Skills & Abilities:
• Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality.
• Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures
• Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
• Familiarity with 21 CFR Part 11 compliance.
• Knowledge of pharmaceutical laboratory and manufacturing systems, utilities, and facilities. Preferred protocol execution experience with controlled temperature units (Kaye validators, Ellab), biological safety cabinets (cleanroom foggers), cryogenic storage systems, etc.
• Experience writing and executing commissioning/qualification/validation documents including VMP, URS, FAT, SAT, IOPQ, RTM, and summary reports
• Experience writing protocol deviations, investigating out of specification results, and performing corrective and preventive actions.
• Ability to interact effectively with cross-functional 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, including 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.
• Strong computer skills in Microsoft Office Suite – Word, Excel and Outlook, and the ability to learn new software as required for equipment qualification.
Competencies:
• Professional Knowledge
• Problem Solving
• Team Player / Building Relationships
• Multi tasking
• Customer Focus
• Action and detail oriented
• Active Listening
• Decisive
3. DUTIES AND RESPONSIBILITIES
1) Maintains all qualified equipment/systems in compliance with policies, guidelines, and procedures:
a. Develops qualification protocols, and associated reports while adhering to a change management process.
b. Supports the execution of equipment/systems qualifications and validation protocols.
c. Supervises vendors for qualification functions.
d. Develops written procedures for calibration and preventive maintenance of equipment and systems.
e. Supports calibration, equipment qualification and system validation activities.
f. Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
2) Manages projects of limited scope and complexity within their functional area:
a. Supports laboratory equipment/systems implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
b. Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment/systems to meet business needs in accordance with required schedules or dates.
c. Completes all calibration, qualification and validation documentation with accuracy, completeness, and compliance to Client standards.
3) Provides excellent customer service and support:
a. Regularly reviews, prioritizes, and promptly responds to customer equipment qualification/system validation and support requests.
b. Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
c. Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
Required Qualifications:
B.S. degree in Engineering or equivalent
Minimum 5 years of experience in FDA – regulated industry, with 3 years of experience in facility/utility/equipment qualification
Must be authorized to work in the US on a permanent basis without sponsorship
Apply Today
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
(phone number removed)
INDE
-
Equipment Validation Engineer
4 weeks ago
Stafford Twp, United States Artech Full timeEquipment Validation Engineer Warren, NJ 100% Onsite Required Required Skills: BS in Engineering or Science related discipline required Minimum 3 years of experience in FDA-regulated industry. Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators...
-
Validation - Validation Specialist
4 weeks ago
Stafford Twp, United States Artech Full timeJob Description: Validation Specialist Warren, NJ--Onsite Work Schedule: Mon - Fri, Business Hours 6 months contract The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments, setup of...
-
Validation Specialist
4 weeks ago
Stafford Twp, United States On-Board Companies Full timeOn-Board Scientific is hiring a Validation Specialist based out of Warren, NJ! For immediate consideration please send your resume to Subject Line: Position Title and State you are located About Us: On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees....
-
Validation Specialist
4 weeks ago
Stafford Twp, United States Mindlance Full timeJob Description: Validation Specialist Warren, NJ--Onsite Work Schedule: Mon - Fri, Business Hours The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments, setup of computers and...
-
Validation Specialist
4 weeks ago
Stafford Twp, United States Axelon Full timeJob Description: Validation Specialist Warren, NJ--Onsite Work Schedule: Mon - Fri, Business Hours The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments, setup of computers and...
-
Validation Specialist
4 weeks ago
Stafford Twp, United States Axelon Full timeJob Description: Validation Specialist Warren, NJ--Onsite Work Schedule: Mon - Fri, Business Hours The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments, setup of computers and...
-
Validation Specialist
3 weeks ago
Stafford Twp, United States Mindlance Full timeJob Description: Validation Specialist Warren, NJ--Onsite Work Schedule: Mon - Fri, Business Hours The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments, setup of computers and...
-
Validation Specialist
3 weeks ago
Stafford Twp, United States Pyramid Consulting Full timeImmediate need for a talented Validation Specialist. This is a 06+ Months Contract opportunity with long-term potential and is located in Warren, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID: (phone number removed) Pay Range: $55 - $62/hour. Employee benefits include, but are not limited to, health...
-
Validation Engineer
3 weeks ago
Plainsboro Twp, United States Kelith Group Inc Full timeKelith Group Inc has openings for the positions of Validation Engineer with master’s degree in Mechanical/Manufacture Engineering, Management, or related and 1 year of exp in executing Engineering test plans (ETP) for new and modified systems/equipment. Develop protocols for validation/testing of eq...
-
Validation Engineer II
2 months ago
Branchburg Twp, United States Amneal Pharmaceuticals Full timeJob Summary The Validation Engineer II is responsible for performing validation and Engineering activities, conducting development studies, analyzation and assist in improving pharmaceutical systems and processes. Essential Functions Design, review and execute validation document activities such as Factory acceptance test (FAT), Installation qualification...
-
Validation Engineer III
4 weeks ago
Branchburg Twp, United States Amneal Pharmaceuticals Full timeJob Summary The Validation Engineer III performs validation and engineering activities; conducts development studies; and monitors, analyzes and assists in improving pharmaceutical systems and processes. Provides detailed reports to management. Essential Functions Design, develop and execute validation documents, define validation strategy. Design, review...
-
Validation Engineer III
2 weeks ago
Branchburg Twp, United States Amneal Pharmaceuticals Full timeJob Summary The Validation Engineer III performs validation and engineering activities; conducts development studies; and monitors, analyzes and assists in improving pharmaceutical systems and processes. Provides detailed reports to management. Essential Functions Design, develop and execute validation documents, define validation strategy. Design, review...
-
Stafford Twp, United States TechDigital Corporation Full timePurpose and Scope: This role supports the successful operation of facilities, laboratories, and business functions at multi-use sites through interaction with internal team members and peer-level customers as well as external service providers. The position focus is on providing technical expertise and decision making while ensuring end-to-end and timely...
-
Branchburg Twp, United States AbbVie Full timeJob Description Onsite position in our Branchburg, NJ, location Purpose: An engineering professional who works with project owners, subject designers/engineers, and other project team members to plan and complete tasks associated with commissioning, qualification, and validation of new and modified equipment, facilities, utilities, products, processes,...
-
Senior Validation Engineer
7 days ago
Branchburg Twp, United States AbbVie Full timeAn engineering professional who works with project owners, subject designers/engineers, and other project team members to plan and complete tasks associated with commissioning, qualification, and validation of new and modified equipment, facilities, utilities, products, processes, etc.in line with project, operations and quality objectives. Additionally,...
-
Senior Engineer, Validation Commissioning
2 weeks ago
Branchburg Twp, United States AbbVie Full timeCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...
-
Cranberry Twp, United States CoreTek Labs Full timePosition: Hardware Verification and Validation Engineer Location: 500 Cranberry Woods Drive Cranberry Township, PA 16066 Duration: Long-term Contract Experience: 8+ years Job Description: Extensive experience in Linux internals. Experience in Bus & Protocol Analyzer such as CATC USB Chief, Wireshark network packet analyser, Beagle I2C/SPI, oscilloscope,...
-
Engineering - Equipment Engineer
1 week ago
Stafford Twp, United States TechDigital Corporation Full time100% onsite PURPOSE AND SCOPE OF POSITION: The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers. The incumbent conducts tasks assigned by the management independently or with...
-
Engineering - Equipment Engineer
4 weeks ago
Stafford Twp, United States TechDigital Corporation Full time100% onsite PURPOSE AND SCOPE OF POSITION: The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers. The incumbent conducts tasks assigned by the management independently or with...
-
Engineering - Equipment Engineer
4 weeks ago
Stafford Twp, United States HonorVet Technologies Full timeJob Description: 100% onsite PURPOSE AND SCOPE OF POSITION: The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers. The incumbent conducts tasks assigned by the management...
