Validation Specialist

While an hourly range is posted for this position, an eventual hourly rate is determined by a comprehensive salary analysis which considers multiple factors including but not limited to: job-related knowledge, skills and qualifications, education and experience as compared to others in the organization doing substantially similar work, if applicable, and market and business considerations. Ultimately, the role of the Validation Engineer is to ensure that all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products.

JOB TITLE: Validaton Specialist Lead
JOB LOCATION: Milford, Ma Must be onsite
WAGE RANGE*: 45 - 50/ hour
JOB NUMBER: 26-01467

REQUIRED EXPERIENCE:
We utilize 2 types of Equipment:
1. Cytiva (Mfg) TFF and Chromatography Process Skids (utilizing NaOH and WFI as the cleaning agent)
2. Stainless Steel 3000L x Vessels (utilizing CIP100/200 & WFI cleaning agents).
I am looking for person with a good understanding of TOC established criteria/calculation (based upon MACO/ADE/PDE/Batch Size, etc.)

In addition, this person shall be capable of run and execute CV Protocols.

• Proven work experience as a Validation Engineer or similar role.
• Strong knowledge of validation principles and practices.
• Excellent analytical and problem-solving skills.
• Proficiency in validation software tools.
• Strong understanding of industry and regulatory standards.
• Ability to work in a cross-functional team environment.
• BSc degree in Engineering or relevant field.

JOB DESCRIPTION

We are searching for a meticulous and experienced Validation Engineer to join our team.
The Validation Engineer's responsibilities include designing validation test methods, conducting process validation studies, preparing detailed reports, and ensuring that all systems meet industry standards.
The ideal candidate should be adept in data analysis, able to maintain updated knowledge of industry trends and advancements, as well as have a deep understanding of validation principles and practices.
Ultimately, the role of the Validation Engineer is to ensure that all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products.

Responsibilities

• Design and develop validation schedules, protocols, and reports that support validation status of equipment, systems, or processes.
• Analyze and validate data to ensure system requirements have been met.
• Conduct validation or performance tests of new or existing processes.
• Document test procedures to ensure reliability and compliance with standards.
• Prepare detailed reports or design statements based on results of validation and testing activities.
• Investigate and diagnose any system failures and provide solutions.
• Work cross-functionally with production and design teams to ensure validations are conducted properly and efficiently.
• Maintain knowledge of current industry trends and advancements.

Equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities

* While an hourly range is posted for this position, an eventual hourly rate is determined by a comprehensive salary analysis which considers multiple factors including but not limited to: job-related knowledge, skills and qualifications, education and experience as compared to others in the organization doing substantially similar work, if applicable, and market and business considerations. Benefits offered include medical, dental and vision benefits; dependent care flexible spending account; 401(k) plan; voluntary life/short term disability/whole life/term life/accident and critical illness coverage; employee assistance program; sick leave in accordance with regulation. Benefits may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions. Benefits offered are in accordance with applicable federal, state, and local laws and subject to change at TCM's discretion.

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