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Validation Specialist I

Company: Alcami Corporation
Location: Durham
Posted on: August 6, 2022

Job Description:

Think Different. Do Different. Be Different.

Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.

Job Summary

Responsibilities for this position involve validation equipment operation, protocol development, protocol execution and associated activities. This position will support a wide range of validation activities, including laboratory and manufacturing equipment of all types, laboratory and manufacturing technical support services, facilities/utilities, computerized systems and data integrity assessment/remediation.

This full-time position works with supervision to gain experience with more experienced staff.

This position is for day shift but may require some occasional off shift overnight and/or weekend coverage to accommodate schedules and/or project timelines.

Essential Duties And Responsibilities

  • Directly support validation projects at external client sites
  • Operate validation test equipment: process meter, data logging systems
  • Independently develop and execute validation protocols and procedures
  • Perform CSV (computer software validation) and data integrity assessment/remediation
  • Support deviation resolution and troubleshooting strategies with client
  • Provide technical support to laboratory and/or manufacturing areas
  • Support positive client interaction and communication
  • All other duties as assigned

    Education, Experience And Qualifications
    • BA/BS in technical or science related field of study. Candidates with an HSD/GED, technical training, or an Associate's degree combined with mechanical aptitude or relevant industry experience
    • Strong working knowledge of IT concepts, strategies, and methodologies
    • Proficient with Microsoft Office (Word Excel, Powerpoint)
    • Strong written and verbal communication skills
    • Strong mechanical skills
    • Strong reporting, organizational and interpersonal skills
    • Ability to multitask and to perform tasks with high quality and accuracy
    • Validation experience or experience working in a GMP regulated environment is a plus, including working knowledge of ISO 9001, ISO 17025, GMP, GLP, GAMP 5 and 21 CFR Part 11

      Physical Demands & Work Environment

      The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

      While performing the duties of this job, the employee is regularly required to stand; using hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 20 pounds, and occasionally lift and/or move up to 50 pounds.

      While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions; outdoor weather conditions; extreme cold (non-weather) conditions; moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate-loud. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to: safety eyewear, various types of respirators/breathing apparatus, half face and full face respirator, lab coats, full protective body coverings, various types of gloves, etc.

      Additional Information
      • Drug testing
      • Inoculations specific to customer sites
      • Travel required
      • Valid driver's license

        What We Offer You:
        • Competitive salary with career advancement opportunities
        • Bonus plan
        • Medical, dental and vision coverage from day one
        • 401(k) with company match
        • Company paid vacation, holiday and sick-leave
        • Voluntary benefits including short & long-term disability, life, accident, critical illness insurances

          Diversity and Inclusion:

          Alcami values diversity and we are c ommitted to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, sexual orientation, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

          As part of our effort to provide and maintain a safe and healthful workplace, Alcami Corporation requires new hires to be fully vaccinated against COVID-19. Individuals are considered fully vaccinated 2 weeks after their second dose of the Pfizer or Moderna vaccine, or 2 weeks after a single-dose of the Johnson & Johnson vaccine. Individuals seeking an exemption from this requirement for medical or religious reasons should contact HR to complete a request for accommodation form.

Keywords: Alcami Corporation, Durham , Validation Specialist I, Other , Durham, North Carolina

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