| Hybrid !! Senior Validation Equipment Engineer role || Cambridge, MA(Locals Only) at Cambridge, Massachusetts, USA |
| Email: [email protected] |
| Job Title: Senior Validation Equipment Engineer Location: Cambridge, MA (Day 1 On-Site- Hybrid Module- Hybrid Module- On-Site 3 days a week offsite 2x a week in Bedford, MA- Non-Local as long as Close Geographical) Duration: 12 Month Contract MOI: Phone then Video Interview Visa: No H1B/TN (Need LinkedIn URL of the Candidate) Job Description: Summary of Primary Responsibilities: This position is responsible for managing the Bedford Sites 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. Responsibilities: Manages the site validation program ensuring timely execution of all validation and revalidation 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 revalidation non-conformances, change controls, work orders. Defines and revises validation master plans (VMPs) and procedures to ensure compliance to US FDA and applicable worldwide regulations. Supports new product and capital project teams by defining and coordinating commissioning and qualification requirements. Provides general technical advice on new equipment and modification to existing equipment to ensure validation/qualification status is maintained in a state of control. Performs other related duties as required. Supervisory Responsibilities: No direct supervisory requirements. Provide technical and project leadership to validation engineering staff and contractors. Experience, Knowledge, and Skills Required: Bachelor's Degree in engineering or life sciences and 7-10 years of validation/engineering experience in pharmaceuticals or medical devices. Subject matter expert in FDA, EMA, ISO 13485, GHTF Process Validation Guidance, ICH qualification / validation, aseptic fill manufacturing, terminal sterilization. Demonstrated situational leadership skills and project management expertise. General Comments: New Equipment will Arrive Q1/Q2 and this person will be responsible for owning the Validation of that moving forward Need a Go getter (Type A) personality here who owns the project and treats it as such! Hybrid work schedule On-Site 3 days a week offsite 2x a week in Bedford MASS. experience leading validation project teams, including use of project planning software and skillset. Thanks & Regards, Pragya Singh | Technical Recruiter Verve IT Consulting Office: 646-462-3600 Ext: 107, Email: [email protected] LinkedIn: linkedin.com/in/pragya3008 3811 Ditmars, Blvd #20 Astoria, NY 11105 || Website: www.verveitconsulting.com Note: Due to high volume of calls, I may miss your call, email is the better way to reach me. Keywords: information technology golang trade national Massachusetts New York Tennessee Hybrid !! Senior Validation Equipment Engineer role || Cambridge, MA(Locals Only) [email protected] |
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| Fri Oct 11 01:20:00 UTC 2024 |