Validation Engineer Salary at Entegee Inc BETA

About The Job Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world’s most complex challenges and deliver more impact together. Role description: Arcadis is seeking a Validation Engineer to join our team and play a critical role in ensuring compliance with industry standards and regulatory requirements for our products and processes. The ideal candidate will have expertise in validation processes and protocols, particularly in the pharmaceutical or biotech industry with a focus on sterilization, environmental monitoring, and utility systems. Role accountabilities: Autoclave Cycle Development and Performance Qualification (PQ): Develop and optimize autoclave sterilization cycles to ensure product steril

Summary of Primary Responsibilities: This position is responsible for managing the Bedford Site’s Validation program that includes start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, and medical device/drug product manufacturing processes according to current Good Manufacturing Practices (cGMP), ISO requirements, and ICH guidelines. Reporting to the Director of Engineering, this position works internally across the Anika organization to define, administer, and continuously improve the site’s validation programs. Responsibilities: Manages the site validation program ensuring timely execution of all validation/re-validation requirements through accurate requirements definition and resource planning Authors, executes, and summarizes qualification and validation protocols Coordinates the investigation, impact assessment and resolution for all validation and re-validation

Position: SIP CIP Validation Engineer Location: Lincoln, RI Long term Contract Job Summary: Responsible for the management and coordination of engineering activities related to CIP (Cleaning In Place) and SIP (Sterilization In Place) with external partners and internal stakeholders. Key Responsibilities: Review CIP/SIP design Develop and implement CIP/SIP strategy Review user requirements for CIP/SIP Coordinate with external parties and internal stakeholders to ensure overall alignment and coordination of CIP/SIP design Requirements: Minimum 5 years of experience in cleaning and sterilization, specifically in validation or engineering within the pharmaceutical industry Extensive knowledge and experience with CIP & SIP validation and design in the pharma sector Engineering Degree (Mechanical or Chemical) or equivalent technical training and experience Thanks Ritika Aithmian Lead Recruiter Ritika.aithmian@mastechdigital.com

Job Title: IT CSV Lead Location: Remote (Cambridge, MA) Duration: 12+ months contract JOB DESCRIPTION: IT CSV Lead JOB DESCRIPTION Our client is a small Therapeutics organization seeking a Computer Systems Validation Lead to support the overall IT Compliance and CSV processes. On a day-to-day basis your key responsibilities will be, and not limited to: · Lead and execute the validation activities for other IT Projects like and not limited to Veeva, SAS, VLMS (Validation Lifecycle Management Software), R Studio · Responsible for tracking monitoring and controlling validation processes to ensure timely delivery to meet prescheduled to releases · Provide technical expertise, interpretation, and direction in regard to computer, validation, federal regulations and other quality requirements · Work with business owners to ensure requirements specifications are defined in a clear testable format · Effectively work with cross functional teams (business owners, technical team, project manager)

***PLEASE NOTE: We are not accepting 3rd party and/or Agency candidates at this time*** Job ID: 617486 Our client, a leading Medical Device company, is seeking an experienced Mechanical/Biomedical Engineer with validation skills. This is a fully onsite role and there are no work-from-home exceptions. Please only apply if you either live in the Boston area or planning to relocate on your own. See below for other tasks/duties! Top 3 technical skills that are required for the role: Validation Experience IQ/OQ/PQ Test Method Validation Problem Solving/Process Improvements Responsibilities: Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specification

Required Skills: Validation Engineer Manufacturing Engineer with Packaging, Cleanroom, Equipment machine validation experience Good communication skill Good experience in validations (IQ/OQ/PQ) 5+ years of Working Experience machine shop environment Good communication skill Machining background Has worked in a Packaging, Cleanroom, Equipment machine shop environment (within med device or aerospace preferred) Product / Manufacturing Transfer activities Good experience validations (IQ/OQ/PQ) Understanding of different types of metal/plastic cutting manufacturing processes Basic understanding of Packaging, clean room, milling and or lathe machines Understanding of basic Quality systems

Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry. We provide biomanufacturing strategy and execution to start up and established gene and cell therapy, pharmaceutical, and biotechnology companies. We are an industry leader in providing project management, validation, engineering, quality/compliance, and consulting services to support our partners in finding ground-breaking treatments and solutions. We are committed to advancing manufacturing to achieve operational excellence and accelerate speed to market for next-generation medicines. Our culture of philanthropy, teamwork, training and development and commitment is the foundation to our teams' and partners' long-term success. Project Farma is a wholly owned subsidiary of Precision Medicine Group, LLC, a leading global life sciences company with over 2,000 employees. Position Summary: The Project Engineer will work collaboratively with partners, vendors, contractors

Duration: 10-11 Months Contract(With possible extension) Job Description: Note: Validation of Computer Systems Do not exceed Scope: Periodic Review of 34 Commercial Off The Shelf (COTS) systems Summer Mapping of the GMP warehouse Winter Mapping of the GMP Warehouse Decommissioning of Legacy Environmental Monitoring System (Hanwell) Asset Introduction and Validation of Wireless Data Logger software and probes (ellab) Responsibilities: Senior CSV Lead: Update the Computerized Systems Validation Master Plan Provide Validation Assessments for any change controls linked to systems. Develop validation protocols in support of any change controls. Execute Validation protocols related to change controls. Close/Update Change Control tasks assigned to Validation. Reviewer/approver of completed periodic reviews. Oversee/Support the Validation of the Wireless data loggers used for temperature mapping. Develop and execute the Validation IOPQ for the wireless data loggers. Oversee the development, re