Commissioning/Qualification Specialist/Validation

2 weeks ago

Trenton, United States American Cybersystems Full time

Innova Solutions is immediately hiring a Validation Specialist

Job Title: Validation Specialist

Position type: Full-time Contract

Duration: 12 Months

Location: Warren, NJ

Onsite

As a Validation Specialist, you will:

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 completion of Facilities and Utilities commissioning and qualification and ongoing work activities of low to moderate complexity, individually and with support of others.

The incumbent spends most of their time on individual work. The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit.

The incumbent in this role works with entry, junior, and experienced level professionals to accomplish daily tasks and short-term projects according to established policies and procedures.

Required Competencies--Knowledge, Skills, and Abilities:

Intermediate knowledge of cGMP pertaining pharmaceutical facilities, utilities, and equipment.

Intermediate knowledge of pharmaceutical manufacturing and utilities that support cell therapy clinical manufacturing.

REQUIRED:

Intermediate knowledge of commissioning and qualification of clean manufacturing facilities, material pass-throughs, AHUs, compressed air, carbon dioxide, and process air systems.

PREFERRED:

Commissioning and qualification of liquid nitrogen supply systems, DI Water, autoclaves, isolators, filling and capping equipment, and airflow visualization studies.

Understanding of scheduling and execution fundamentals.

High proficiency in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook. Innate ability to learn new software, such as corporate intranet and enterprise business.

Working knowledge of scheduling software and systems, and inventory management systems.

Commissioning and Qualification:

Administer change control activities and corrective and preventive actions.

Review, approve, and execute test protocols, validation deliverables, and plans as needed.

Author, review, and approve SOPs, work practices, and other procedural documents.

Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.

Serve as an SME for change controls, investigations, CAPAs, and audits, as applicable.

Promotes and 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 equipment commissioning and qualification. Interfaces with customers to ensure all expectations are met.

Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.

Communication and Management of Timelines:

Ensures timely completion of equipment commissioning and qualification projects, individually and/or with support of contracted personnel.

Develops an effective mechanism for communicating the current status of all manufacturing and laboratory equipment to affected stakeholders.

Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.

Regulatory Responsibilities:

Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other Client standards and regulations.

Acts as equipment commissioning and qualification SME in internal and regulatory audits.

Education and Experience:

BS in Engineering required. Must be able to read and understand construction and mechanical drawings and P&IDs.

Minimum of 3 years of experience in FDA-regulated industry.

Minimum of 3 years of experience developing and execution facility and utility qualification.

Strong background and experience in laboratory and manufacturing operations.

Knowledge of cGMP in the pharmaceutical industry.

Thorough knowledge and hands-on experience with airflow visualization (smoke studies).

Strong computer skills, knowledge of calibration management and environmental monitoring systems preferred.

Experience interacting with external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions is preferred.

Qualified candidates should

APPLY NOW

for immediate consideration Please hit

APPLY

to provide the required information, and we will be back in touch. To view the full job description, click

here .

#J-18808-Ljbffr

  • Qualification Specialist

    2 weeks ago

    Trenton, United States Synkriom Full time

    Job DescriptionJob Description Commissioning/Qualification Specialist/Validation 100% Onsite --Warren, NJ--Local candidates only Work Schedule: Mon - Fri, Business Hours'' DUTIES AND RESPONSIBILITIES 1) Commissioning and Qualification: a. Administer change control activities and corrective and preventive actions. b. Review, approve, and execute test...

  • Senior Validation Specialist

    5 days ago

    Trenton, United States Ferring Holding SA Full time

    Senior Validation Specialist page is loaded Senior Validation Specialist Apply locations Parsippany, New Jersey, United States time type Full time posted on Posted 7 Days Ago job requisition id R0027187 Job Description: As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and...

  • Validation Specialist

    5 days ago

    Trenton, United States PharmaLex Full time

    JOIN OUR TEAM! PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork,...

  • Validation Specialist

    2 weeks ago

    Trenton, United States Integrated Resources Full time

    Job Title: Validation Specialist Job Location: Warren, NJ Job Duration: 5 Months Work Schedule: Mon - Fri, Business Hours Job Description: The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory...

  • Validation Specialist

    1 week ago

    Trenton, United States Integrated Resources Full time

    Job Title: Validation SpecialistJob Location: Warren, NJJob Duration: 5 MonthsWork Schedule: Mon - Fri, Business HoursJob Description: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,...

  • Validation Specialist

    1 week ago

    Trenton, United States Synkriom Full time

    Job Description Job Description 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 instruments, troubleshooting of system related issues, and technical writing...

  • Validation Specialist

    2 weeks ago

    Trenton, United States Knewin Full time

    Job Description: Validation SpecialistWarren, NJ--OnsiteWork Schedule: Mon - Fri, Business HoursThe 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 instruments,...

  • Validation Engineer/Specialist

    6 days ago

    Trenton, United States IPS-Integrated Project Services, LLC Full time

    Job Description: At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Validation Engineer to join our talented team at our office located in Somerset, New Jersey . In this role, you will perform cGMP compliance-based services...

  • Validation Specialist

    2 weeks ago

    Trenton, United States System One Full time

    Job Title : Validation Specialist Location : Warren, NJ Hours/Schedule : Mon - Fri, Business Hours Type: Contract Responsibilities Performs validation document generation, program management, and protocol execution activities. Interface with Engineering, and end user groups to support development of life cycle documents and system requirements. Design the...

  • Validation Specialist

    7 days ago

    Trenton, United States Pyramid Consulting Full time

    Immediate 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: 24-21500 Pay Range: $55 - $62/hour. Employee benefits include, but are not limited to, health insurance...

  • Computer Systems Validation Specialist

    7 days ago

    Trenton, United States LabVantage Full time

    LabVantage Solutions, Inc. Computer Systems Validation Specialist Somerset , New Jersey Apply Now A.Job Description ObjectiveLabVantage Professional Services (PSO) are expanding their team to provide an increased level of Computer Systems Validation (CSV) services and solutions, to address growing customer needs. As a key member of the LabVantage PSO team,...

  • Software Validation Specialist

    5 days ago

    Trenton, United States Binaryitech Full time

    The Software Validation Specialist will collaborate closely with the Clinical Quality Assurance Lead for Systems Audits, focusing on audit and quality Participate in computer system audits to review SDLC and data integrity controls. Review CAPA and verify CAPAs of system audits. Act as a QA approver for internal validation efforts. Serve as a liaison to the...

  • Validation Specialist

    2 weeks ago

    Trenton, United States System One Holdings Llc Full time

    Job Title : Validation SpecialistLocation : Warren, NJHours/Schedule : Mon - Fri, Business HoursType: ContractResponsibilitiesPerforms validation document generation, program management, and protocol execution activities.Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.Design the...

  • Validation Specialist

    2 weeks ago

    Trenton, United States System One Full time

    Job Title : Validation SpecialistLocation : Warren, NJHours/Schedule : Mon - Fri, Business HoursType: ContractResponsibilitiesPerforms validation document generation, program management, and protocol execution activities.Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.Design the...

  • Validation Engineer

    2 weeks ago

    Trenton, United States Acara Solutions, An Aleron Company Full time

    Acara Solutions is seeking a Validation Engineer for its successful client who are a leading world supplier of integrated processing solutions for customers in the area of pharmaceuticals, food processing, feeds and fine chemicals. Our products and services stand for reliability and quality worldwide. Compensation: $100 - 120K & excellent employee Benefits...

  • Qualification Engineer

    2 weeks ago

    Trenton, United States Tris Pharma Full time

    Description Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in...

  • Validation Engineer I, Engineering

    1 month ago

    Trenton, United States Amneal Pharmaceuticals Full time

    Job Summary The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements. Essential Functions Assist in the preparation/ execution of Installation Qualification(IQ)/Operational Qualification(OQ)/ Performance...

  • Senior Equipment Validation Engineer

    2 weeks ago

    Trenton, United States Rbw Consulting Full time

    RBW Consulting are excited to present an opportunity for a Senior Validation Engineer with a CDMO partner of ours! With over 20 years experience in the industry, they are passionate about supporting companies from Development to Commercial launch of their Sterile products, with a particular focus on Injectables. Dedicated to quality and growth, our partner...

  • Sales and Education Specialist

    7 days ago

    Trenton, United States Astral Brands Full time

    Job Type Part-time Description The Pür Sales and Education Specialist's primary responsibilities are to assist the Account Executive to achieve sales plan, gain market share, and drive brand awareness. Essential Duties and Responsibilities: • Build and nurture strong relationships with store staff and retail management in ULTA • Train, educate and...

  • Intervention Specialist

    4 weeks ago

    Trenton, United States Butler County Area Application Consortium Full time

    Position Type: Intervention SpecialistDate Posted: 1/2/2024Location: Edgewood Middle SchoolDistrict: Edgewood City Schools - websiteEdgewood Middle School Intervention Specialist 2024/2025 School Year QUALIFICATIONS High School Diploma or equivalent Valid Driver's license Appropriate State of Ohio Teaching License A satisfactory report from Criminal...