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Engineer III

Company: Advanced Clinical
Location: Bedford
Posted on: May 16, 2022

Job Description:

OverviewWe are currently searching for a skilled professional to join a well-known client's team as a Validation Engineer III in Bedford, Massachusetts. The Validation Engineer III role Leads start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, medical device, and drug product manufacturing processes
Responsibilities

  • Leads the delivery of validation within complex, capital projects overseeing engineering, quality, and compliance aspects of validation.
  • Authors, executes, and summarizes qualification and validation protocols. - Conducts Risk / Impact assessments and establish system boundaries.
    • Ensures protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards and approved SOPs.
    • Coordinates the investigation and impact assessment for all deviated equipment or processes discovered upon calibration or validation.
    • Initiates, or provides validation input on quality systems such as CAPAs and change controls.
    • Responsible for other duties and projects as assigned.
      Experience - Bachelor's Degree in Engineering, science, or closely related discipline is desired with 5+ years of significant engineering and or operational experience. - Advanced degree or post-graduate coursework may be desirable. - 5-8 years of validation experience in pharmaceutical, medical device or FDA regulated environments. - Strong understanding of cGMP and regulations related to facility, utility, equipment, and process validations. - Ability to initiate, manage and close quality systems such as change control, CAPA and deviation management. - Detailed experience performing root cause analysis investigations for deviations and non-conformances having technical scope. - Excellent written and verbal communications skills.
      Desired Experience, Knowledge, and Skills: - Solid understanding of quality risk management principles and statistical concepts as applicable to area of responsibility. - Subject matter expert on regulations and best practices pertaining to validation. - Practical application and knowledge of ISO 13485, GHTF Process Validation Guidance and other applicable standards used in the medical device manufacturing. To Be a Best-fit Your Strengths Must Include
      • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
      • Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
      • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
      • Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
      • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
      • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.About Advanced ClinicalAdvanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com. Regarding your applicationPlease know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.501801

Keywords: Advanced Clinical, Boston , Engineer III, Engineering , Bedford, Massachusetts

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