Validation Engineer IV - South Plainfield, United States - Katalyst HealthCares & Life Sciences

Katalyst HealthCares & Life Sciences South Plainfield, United States

1 week ago

Freelance

Description

Responsibilities:

Develop and approve cGMP documents including, but not limited to: Equipment and instrument Qualification, Commissioning, Master Validation Plans, SOP's, Comparability reports, Aseptic Process simulation protocols and reports; process validation (PPQ), and cleaning/sterilization validation.

Lead validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, SAT, IQ, OQ, PQ) etc.

Ensuring that the Validation department meets or improves key performance indicators (KPIs).

Works to ensure all validation projects are on time and on budget. Ensures adequate validation resources. May manage validation consultants on a large project basis, as needed.

Leading and Managing projects for the validation of equipment, processes, and products to meet all safety, quality, regulatory and operational requirements.

Review of equipment specification/design/procurement/installation and validation.

Project planning and execution including scheduling, task management, milestone planning and reporting.

Generation, review, and approval of project documentation (User Requirement Specifications, validation protocols, reports) and Standard Operating Procedures

Lead validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQ, OQ, PQ, etc.).

Employee will be required to work closely with both manufacturing, quality, and engineer associates.

Maintaining the validation sample management, assessing the requirements for data acquisition, and coordinating validation projects.

Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.

Position flows based on project needs up to and including quality approvals.

Undertaking any other duties for any department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.

Scientific degree (ideally:
pharmaceutical sciences, engineering, chemistry, or related discipline).

Strong knowledge of cGMP's.

Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.

Biotech and/or Sterile manufacturing and aseptic processing knowledge required.

Experience in Computerized System Validation (CSV).

Biopharma Process Experience

Minimum of 10-15 years' experience in validation (with degree 10+: without 15+), biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.

Knowledge of cGMP's and Data Integrity principles.

Demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Good personal leadership.

Good communicator (written and verbal) at all levels.

Customer focused. Strong analytical and problem-solving ability.

Hands-on approach, with a 'can do' attitude. Able to work under minimal or appropriate supervision level.

Ability to prioritize, demonstrating good time management skills.

Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.

Self-motivated, with the ability to work proactively using own initiative.

Highly Desirable:

Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP desirable but not required.

Requirements:
Detail oriented individual must be able to work alone and complete tasks without requiring much supervision.

Must be able to meet deadlines and produce quality work consistently.

Engages in the day-to-day activities of the Validation function, ensuring the successful management of related activities and large projects.

Supports Validation objectives, whilst adhering to regulatory compliance and achieving commercial success.

This is a site-based position supporting the facility and will require gowning into the manufacturing suites. Bring equipment in/out of the cleanrooms as per procedure.

Ensures the Validation function supports operational needs and ensures regulatory compliance requirements are met.

CQV experience is a must and good understand Commissioning, Qualification, and Validation protocols and final reports. Able to write final reports and technical deviations, if needed during CQV execution.

Skills Required:
Validation protocols, Validation engineer, Regulatory compliance, Detail oriented.

#J-18808-Ljbffr

validation engineers

2 weeks ago

United Pharma Technologies Inc South Plainfield, United States

VALIDATION ENGINEERS - United Pharma Technologies, Inc. - South Plainfield, NJ So. Plainfield, NJ & other unantcptd locns nationwide. Duties: Analyze validation test data to determine whether systems or processes have met validation criteria & to identify root causes of problems ...
Validation Engineer

1 week ago

Katalyst HealthCares & Life Sciences South Plainfield, United States

Roles & Responsibilities · : · Responsible to create and execute qualification protocols (IQ/OQ/PQ), including identification and resolution of non-conformances/deviations. · Responsible to initiate the preparation and calibration of thermocouple for Kaye AVS/Ellab to monitor ...
Validation Engineer

1 week ago

Katalyst Healthcares and Life Sciences South Plainfield, United States

Roles & Responsibilities:Responsible to create and execute qualification protocols (IQ/OQ/PQ), including identification and resolution of non-conformances/deviations. · Responsible to initiate the preparation and calibration of thermocouple for Kaye AVS/Ellab to monitor and recor ...
validation engineers

1 week ago

UNITED CONSULTING HUB, INC. Metuchen, United States

VALIDATION ENGINEERS - UNITED CONSULTING HUB, INC. - METUCHEN, NJ Metuchen, NJ & other unantcpt'd locns nationwide. Duties: Analyze validation test data to determine whether systems or processes have met validation criteria & to identify root causes of problems for various pharma ...
validation engineers

1 week ago

Shoolin Iselin, United States

Manage specification, qualification and validation requirements. Write and execute engineering change orders related to Corrective and Preventive Actions (CAPAs), changes in Critical to Quality (CTQs), release of aging reports, updates to design history files. Conduct Risk based ...
Validation Engineer

1 week ago

INTELLECTT INC Iselin, United States

Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems. Conduct Risk based verification for GxP (GMP, GCP, and GLP) systems and laboratory equipment. Participate in medical device manuf ...
Validation Engineer,packaging

1 week ago

Katalyst Healthcares and Life Sciences South Plainfield, United States

Roles&Responsibilities: · Pack Bay 3 will be repurposed to be a dedicated line for the packaging of autoinjector devices for client WCS-081. The new packaging line will be utilizing equipment from the existing line as well as bringing in new equipment. The existing equipment tha ...
Validation Engineer,packaging

4 days ago

Katalyst Healthcares and Life Sciences South Plainfield, United States

Roles&Responsibilities: · Pack Bay 3 will be repurposed to be a dedicated line for the packaging of autoinjector devices for client WCS-081. The new packaging line will be utilizing equipment from the existing line as well as bringing in new equipment. The existing equipment that ...
Validation Engineers

4 days ago

INTELLECTT INC Iselin, United States

Validation Engineers - Intellectt, Inc - Iselin, NJ Iselin, NJ & various unanticipated locations throughout the U.S: Mng spec, qualification & valdtn rqmts. Write & execute engg chng orders rltd to Corrective & Preventive Actions (CAPAs), chng in Critical to Qlty (CTQs), release ...
validation engineers

1 week ago

INTELLECTT INC Iselin, United States

VALIDATION ENGINEERS - Intellectt, Inc - Iselin, NJ Iselin, NJ & various unanticipated locations throughout the U.S: Mng spec, qualfctn & valdtn rqmts. Write & exec engg chng orders rltd to Corrective & Preventive Actions (CAPAs), chngs in Critical to Qlty (CTQs), release of agin ...
Validation Engineers

1 week ago

Shoolin Iselin, United States

Validation Engineers - Shoolin, Inc - Iselin, NJ Iselin, NJ & various unanticipated locations throughout the U.S: Mng spec, qualification & valdtn rqmts. Write & execute engg chng orders rltd to Corrective & Preventive Actions (CAPAs), chng in Critical to Qlty (CTQs), release of ...
Validation Engineer

1 week ago

Kashiv BioSciences LLC Piscataway, United States

Key Duties & Responsibilities · Draft and implement Quality System documentation including SOPs and Traceability Matrix designed to establish good validation practices within the organization. · Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guideline ...
Product Validation Engineering Technician

2 days ago

Cummins New York, United States

**Product Validation Engineering Technician · - 1st Shift** · **Pay Range $30.46- $45.69** · Our culture believes in _POWERING YOUR POTENTIAL_. We provide global opportunities to develop your career, make your community a better place and work with today's most innovative thinker ...
Validation Engineering Consultant

1 week ago

Project Farma (PF) Plainfield, United States

This role can involve up to 100% Travel · Why Precision for Medicine? · Welcome to the forefront of innovation in cutting edge patient treatments. We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science i ...
Validation Engineer

1 week ago

Sun Pharmaceutical Industries New Brunswick, United States

Job Title: Validation Engineer - Pharmaceutical · Job Summary: · The Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements ...
Validation Engineer

1 week ago

Katalyst HealthCares & Life Sciences Avenel, United States

Responsibilities: · Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and client's corporate principles, quality policies, standards, and core ...
Validation Engineering Consultant

1 week ago

Project Farma Plainfield, United States

This role can involve up to 100% Travel · Why Precision for Medicine? · Welcome to the forefront of innovation in cutting edge patient treatments. We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science ...
Validation Engineer II

2 weeks ago

Amneal Pharmaceuticals Piscataway, United States

: · 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 docume ...
ProBio-Validation Engineer

1 week ago

GenScript Piscataway, United States

About GenScript · GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major cat ...
Validation Engineer I, Engineering

2 weeks ago

Amneal Pharmaceuticals Piscataway, United States

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/ exec ...

Validation Engineer IV - South Plainfield, United States - Katalyst HealthCares & Life Sciences

Description

validation engineers