US - New Jersey - Trenton
July 2, 2024
Validation Qualification Specialist
This role is 100% Onsite
Work Schedule: Mon - Fri, Business Hours
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 equipment qualification and computer system 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.
2. REQUIRED COMPETENCIES:
Knowledge, Skills & Abilities:
• Excellent 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. Preferred experience with Kaye validators, BSCs, refrigerators, welders, etc.
• 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
• 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
• Multitasking
• 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.
4) EDUCATION AND EXPERIENCE
a. B.S. degree in Engineering or equivalent.
b. Minimum 5 years of experience in FDA - regulated industry, with 3 years of experience in equipment qualification and computer system validations.
•
United States - NJ - NJ - Parsippany
June 29, 2024
NEW OPENING! Full Time Child Psychiatrist needed in Parsippany, NJ! Call Me Today to Schedule Interview Northern New Jersey (Parsippany) Facility is seeking a Child Psychiatrist for 40 hours per week. • Primarily Monday-Friday, program hours are 8am-5pm. • Population ages 10-18. • Acute Psychiatric...
United States - NJ - NJ - New Brunswick
June 29, 2024
Firstat Medical Staffing is seeking a travel nurse RN PCU - Progressive Care Unit for a travel nursing job in New Brunswick, New Jersey. & Requirements • Specialty: PCU - Progressive Care Unit • Discipline: RN • Start Date: 07/22/2024 • Duration: 13 weeks • 36 hours per week • Shift: 12 hours,...
United States - NJ - NJ - South Plainfield
June 29, 2024
W2 contract/ full time only • Title : AWS Engineer with GCP and Lambda • Onsite: Sunnyvale or Austin (Sunnyvale preferred) • Contract: w2 only • • Seeking a person experienced in AWS technologies with particular emphasis on KMS, Cloud Trail and Lambda products. The project is centered around...
Tender Touch Rehab Services LLC
United States - NJ - NJ - Blairstown
May 29, 2024
Overview: Must be a licensed and or a registered therapist to be considered. * EXCLUSIVE NEW JOB OPPORTUNITY!!* *Highly competitive rates and benefits package! * Do you know a therapist who's a perfect fit for our team? EARN UP TO $1,000 by referring a clinician to the Enhance family of brands! Make...
United States - NJ - NJ - Trenton
June 29, 2024
About the job Part Time Registered Dental Hygienist Hamilton Township, NJ • Part Time Registered Dental Hygienist Hamilton Township, NJLocation: Hamilton Township, NJ • We are a Privately owned Dental Practice that is looking to add a Dental Hygienist to our team! • Our team is established,...
United States - NJ - NJ - PITMAN
June 29, 2024
Unit Description: • Your nutritional know-how can help residents in your community live happier, healthier lives. Sodexo is seeking a Part-Time Registered Dietitian to work 16 hours per week for United Methodist Communities atPitman, a senior care community located in Pitman, NJ. This position...
United States - NJ - NJ - Browns Mills
June 29, 2024
Position Summary: Performs routine and special diagnostics testings and lab procedures in various specialty sections of the Clinical Laboratory in a prompt, accurate and reliable manner according to established hospital and departmental policies and procedures. These specialty sections include...
United States - NJ - NJ - Paramus
June 29, 2024
Zeel is seeking licensed massage therapists to provide on-location massage therapy in homes, offices, and spas in New Jersey. For in-home appointments, therapists earn $90 for 60-minute appointments in New Jersey and $127.50 for 90-minute appointments. • Zeel's Wellness Massage Platform* •...
United States - NJ - NJ - Ridgewood
June 29, 2024
IDR Healthcare is seeking a LPN / LVN for a travel job in Ridgewood, New Jersey. & Requirements • Specialty: LPN / LVN • Discipline: LPN / LVN • Start Date: 07/08/2024 • Duration: 13 weeks • 40 hours per week • Shift: 8 hours • Employment Type: Travel IDR Healthcare is an awarding winning staffing...
United States - NJ - NJ - Hoboken
June 29, 2024
RSVLTS is hiring a passionate and dynamic Paid Social and Search Coordinator to join our growing marketing team. • This position is is integral to enhancing our brand's presence, creating strategic plans for both prospecting and remarketing/retention campaigns, driving targeted traffic, and boosting...
United States - NJ - NJ - Monroe Twp
June 29, 2024
Cranbury Center • 3Class: CNA Note: E/O weekend required Notice: • Registry Personnel must bring a state or federal issued identification to the facility and wear a photo badge at all times. • Agency staff must have completed the original or updated COVID-19 vaccine or present a documented religious...
United States - NJ - NJ - Denville
June 29, 2024
Overview • Prime Healthcare is an award-winning health system headquartered in Ontario, California. • Prime Healthcare operates 45 hospitals and has more than 300 outpatient locations in 14 states providing more than 2.6 million patient visits annually. • It is one of the nation's leading health...
United States - NJ - NJ - Edison
June 29, 2024
We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. • Our exceptional people are the key to our unrivaled, inclusive culture and talent...
United States - NJ - NJ - Red Bank
June 29, 2024
Overview Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are...
Mr Handyman of Cape Cod and the Islands
United States - NJ - NJ - Little Ferry
June 29, 2024
Are you seeking independence? Have you worked hard to acquire the skills and experience of a professional, do quality work, get great customer feedback, and yet still feel micro-managed and unappreciated today? Are you ready to be supervised like an adult; working independently with customers to...
United States - NJ - NJ - Montville
June 29, 2024
Come grow with Marotta, named one of New Jersey's Top Workplaces for the third year running and a Top Workplace USA for 2024.You will have room to grow and be a part of an exciting team, all within a warm and welcoming environment. • We specialize in the design, development, and production of...
The Jewish Home for Rehabilitation and Nursing
United States - NJ - NJ - Freehold
June 29, 2024
$5,000 Sign-On Bonus for all RNs!! • $2,000 Sign-On Bonus for all Part-Time positions!!! • Now offering, "NO FRILLS," - waive benefits, PTO & Holidays get $3 more on the hour for all RNs!! • NOW HIRING FULL-TIME 7-3* • Same Day Pay Available and Amazing benefits for all RNs!...
United States - NJ - NJ - Ridgewood
June 29, 2024
RTG Medical-LTC is seeking a LPN / LVN for a travel job in Ridgewood, New Jersey. & Requirements • Specialty: LPN / LVN • Discipline: LPN / LVN • Start Date: 07/08/2024 • Duration: 8 weeks • 40 hours per week • Shift: 8 hours • Employment Type: Travel RTG Medical-LTC Job ID #6uv6d. Pay package is...