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Equipment Validation Engineer

Company: Enser Corporation
Location: Rockville
Posted on: June 12, 2022

Job Description:

Opportunity Details Equipment Validation Engineer Location: Rockville, MD Salary : $90,000 - $110,000 Type: Direct Equipment Validation Engineer Requirements: We are seeking an Equipment Validation Engineer to support the team. The Equipment Validation Engineer will report directly to the Validation Manager, and work across teams, including Operations and Quality, to help ensure that direct impact equipment is qualified and maintained in a qualified state. The Equipment Validation Engineer will also lead the effort to commission no impact equipment systems as needed. Equipment Validation Engineer Duties/Responsibilities: Participate in development of User Requirements, Installation, Operational, and Performance Qualification Protocols Execute IQ/OQ/PQ protocols Knowledge of Good Documentation Practices Knowledge of the equipment delivery standards such as 21 CFR Part 11 Compliance, Data Integrity, and ASTM2500 Assist in the writing of Standard Operating Procedures (SOPs) Lead direct impact equipment validation efforts Lead no-impact equipment commissioning efforts Support Cleaning Validation and Process Validation as necessary Support third-party qualification and commissioning efforts Contribute to System Classification and System Risk Assessment activities Assist the Research and Development (R&D) engineering and chemistry teams in defining requirements and reviewing Engineering Turnover Packages (ETOPs) Lead efforts for Periodic Review of Qualified Equipment Support the creation and execution of Change Controls and CAPAs Systems include: Clean rooms Aseptic Filler Air Handlers Steramist sanitizer Vision inspection Filter integrity testing Climet particle counters Dispensing Powder-Containment hood Dispensing Scales Custom-made in-house equipment Required Skills/Abilities: A "Can do" problem solving attitude and approach. Effective communication skills and an ability to work efficiently across multi-disciplinary teams to help achieve organizational objectives Excellent analytical and problem-solving skills. Excellent written and verbal communication skills. Excellent organizational skills and attention to detail. Adept at navigating and building strong and professional relationships with all ODP personnel and partners. Sets an example by modeling the required behaviors and holding other employees and peers accountable for their actions by identifying and acting on behavior which is inconsistent with company and safety standards. Able to multitask and adapt quickly to new requests and needs. Contributes to a work environment where performance management, continuous quality improvements in service and professional practice are pursued. Preferred Skills/Abilities: Equipment Validation experience within the medical device, laboratory, or pharmaceutical industries Good understanding and application of Current GMPs, regulatory requirements, and Good Engineering Practices. Excellent communication / interpersonal skills Be a motivator and leader within the team Attention to detail Education and Experience: Bachelor's degree in science/engineering/computer systems as a minimum. At least 5 years of experience in delivering validation projects COVID-19 Vaccination Policy: ?With limited exceptions, up to date COVID-19 vaccinations are required for all ODP employees who work on-site at our headquarters. Employees must present proof of full vaccination (ex. CDC card) or submit exemption requests to the Director of People Operations before their start date. Exceptions to the policy are available only for those who need an accommodation for a qualifying medical reason or sincerely held religious belief or practice.??PI181509884

Keywords: Enser Corporation, Rockville , Equipment Validation Engineer, Engineering , Rockville, Maryland

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