Validation Engineer

Company: Advanced Clinical
Location: Long Beach
Posted on: June 23, 2022

Job Description:

OverviewWe are currently searching for a skilled professional to join a well-known client's team as a Validation Engineer in Long Beach, California. This role will analyze validation data, prepare summary reports, and provide recommendations for improvement in the manufacturing process and equipment. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.Responsibilities

• Develop training packages and JSAs
• Write BKM for Validation
• Serve as a dependable liaison between client departments
• Identify, respond to, and monitor potential project risk and determine possible contingency plans for risk mitigation
• Review technical and quality system documents such as SOPs, Change Control, Deviation Reports, Batch Production Records, Technical Manuals, P&IDs, construction, as-built, and flow diagrams as they relate to validation principles and regulatory compliance issues
• Develop and execute commissioning/qualification protocols for packaging equipment and automation systems
• Establish operating specifications and work instructions for processes and equipment
• Commission and qualify equipment/systems with minimum interruption to client operationsExperience
  • Minimum of 3 years of experience in a relevant field required
  • Demonstrated understanding and application of validation lifecycle principles, concepts, practices, and standards
  • Strong proficiency in current GMPs and safety regulations
  • Extensive knowledge of pharmaceutical equipment, pharmaceutical packaging equipment, serialization, and root cause failure analysis
  • Detailed experience in biotech or pharmaceuticals industry specifically related to packaging equipment
  • Good experience qualifying pharmaceutical packaging equipment
  • Excellent understanding and application of current industry practices for commissioning and qualification
  • Demonstrated Serialization and Aggregation equipment and systems experience desired
  • Strong Project Management expertise with the ability to achieve deadlines and key milestones
  • Good Financial Management skills with the capability to deliver the project on budget
  • Extensive experience in creating and completing cGMP documentation for URS, FRS, DS, Commissioning, qualification, and Turn Over Packages EDUCATION
    • Minimum of a Bachelor's Degree required
    • Master's Degree preferredTo 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. 502343

Keywords: Advanced Clinical, Long Beach , Validation Engineer, Engineering , Long Beach, California