- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices
- Experience in the qualification of cell therapy equipment is highly preferred
- Advanced knowledge of pharmaceutical, manufacturing and laboratory systems
- Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry
- Strong written and verbal communication skills
- Excellent interpersonal skills with experience dealing with a diverse workforce
- Strong multi tasking ability in conjunction with proven organizational skills. 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
- Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business
- BS in Engineering or Science related discipline required
- Minimum of 5 years' experience performing/supporting activities in a GMP environment
- Minimum of 3 years' experience in equipment, facility or utility qualification
- Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs
- Ability to sit, stand, walk and move within workspace for extended periods
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.
- Primarily office environment, but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes
- Ability to work safely and effectively when working alone, or working with others.
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Validation Engineer - Summit, United States - On-Board Companies
Description
On-Board Services is hiring a Validation Engineer in Summit, NJFor 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 / 6-month contract with strong possibility of extension
Job Location: Summit, NJ (100% on-site)
Benefits: Health Insurance (Medical, Dental, Vision), Life Insurance, 401(k)
Compensation: $65 - $79/hr, depending on qualifications
PURPOSE AND SCOPE OF POSITION:
The Equipment Validation Engineer supports the successful implementation of various process/lab
equipment at multi-use sites through interaction with internal customers and external service
providers. The incumbent in this is tasked with commissioning and qualifying new equipment
facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity. 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.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
1) Maintains 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 qualifications and validation protocols.
c. Supervises vendors for qualification functions.
d. Develops written procedures for calibration and preventive maintenance of equipment.
e. Supports equipment qualification and 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 equipment 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 to meet business needs in accordance with required schedules or dates.
c. Completes all 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 and support requests
b. Provides technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
c. Provides technical support and guidance on equipment and computer systems qualification and validations issues.
d. Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
4) Regulatory Responsibilities
a. Ensure equipment, facilities and programs are maintained in compliance.
b. May be called upon as SME in both internal and regulatory audits.
WORKING CONDITIONS:
Physical / Mental Demands:
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.
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