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Validation Engineer I / II

Validation Engineer I / II

Ossium HealthIndianapolis, Indiana, USA
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About the Job

Ossium Health is seeking a skilled and detail-oriented Validation Engineer to lead Commissioning Qualification and Validation (CQV) activities at our GMP manufacturing facility. This role supports clinical production facility upgrades capital expansion projects and laboratory systems. The Validation Engineer will troubleshoot complex systems and lead initiatives that enhance the performance reliability and regulatory compliance of equipment facilities and processes. This position may be upleveled to a Validation Engineer II position for qualified candidates.

Required Qualifications

Education & Experience

  • Bachelors degree or higher in Engineering
  • 2 years of experience in engineering validation or related discipline with at least 2 years of that experience in GMP environments within pharmaceutical biotech or other regulated industries

Technical Skills

  • Strong knowledge of and hands-on experience with equipment qualification in a regulated environment
  • Proficient in technical writing with good documentation practices
  • Skilled in risk assessment root cause analysis and data analysis (e.g. statistical quality control)
  • Experienced in evaluating processes equipment and products for sources of variation and reliability concerns
  • Proficient in performing and documenting deviations investigations and change controls
  • Able to influence without direct authority and adapt to evolving manufacturing needs
  • Strong communication skills and proven ability to collaborate across functions
  • Ability to quickly learn and integrate new technical subject matter

    • Key Responsibilities

    Commissioning Qualification and Validation (CQV)

  • Plan execute and document CQV activities for facilities utilities manufacturing equipment and laboratory systems.
  • Prepare review and approve validation protocols (DQ IQ OQ PQ) in compliance with GMP standards and corporate policies.
  • Conduct qualification testing of equipment and utilities generate associated reports and ensure readiness for GMP operations.
  • Lead revalidation activities triggered by change controls periodic reviews or deviations.
  • Provide validation oversight for capital expansion projects and new equipment installations.

    • Equipment SME and Technical Owner

  • Develop and maintain SOPs work instructions validation master plans and templates to ensure proper operation of equipment and systems.
  • Evaluate equipment and processes to identify critical parameters impacting product quality.
  • Perform risk assessments for instruments equipment processes and products.
  • Maintain and manage master equipment and instrument inventories.
  • Define track and ensure completion of preventive maintenance (PM) strategies.
  • Perform PMs and calibrations as a backup resource.
  • Oversee the equipment reliability program including tracking and trending performance data.

    • Operational Support

  • Serve as escalation support for equipment facility utility and reliability issues unresolved by operations or maintenance personnel to ensure uninterrupted production
  • Collaborate with cross-functional teams to support product launches equipment qualifications project deliverables and continuous improvement initiatives.
  • Train personnel on correct equipment operation and maintenance
  • Support internal and external audits to ensure engineering programs meet corporate and regulatory expectations
  • Lead investigations root cause analyses and corrective / preventive actions for equipment-related deviations
  • Manage change controls related to facilities utilities and equipment
  • Serve as the engineering representative on Ossiums Integrated Operations Team

    • Physical Requirements

  • Must be able to work aseptically in controlled environments requiring special gowning (ie. over the head face hands feet and body)
  • Must be able to work in a moderately noisy environment
  • Must be able to work around biohazardous materials and chemicals
  • Must be able to lift push pull and / or carry up to 50 lbs
  • Must be able to use hands and fingers to handle and feel objects tools and controls
  • Must be able to sit or stand for long periods of time. Regularly required to sit stand walk climb stoop kneel crouch; use hands to handle or feel; and reach with arms

    • In your first six months some projects youll work on include :

  • Qualification of new equipment (e.g. cryotanks) : Lead qualification activities to bring critical equipment online in support of expanding operations
  • Equipment reliability improvements : Establish baselines for key equipment performance implement monitoring and trending systems and drive corrective actions to reduce downtime and increase consistency
  • Maintenance strategy development : Define preventive maintenance plans for critical utilities instruments and manufacturing equipment. Partner with operations and facilities teams to ensure execution and documentation meet GMP expectations

    • We offer a full slate of employee benefits including :

  • Competitive salaries
  • Stock options
  • 401(k) matching
  • Medical dental and vision coverage
  • Four weeks of PTO accrued (vacation & sick time) annually 11 company holidays
  • Employer paid life insurance and long term disability
  • Gym membership / recreational sports reimbursements

    • Ossium Health provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race color religion sex national origin age disability protected veteran status sexual orientation gender identity gender expression or any other protected characteristic. Our Equal Employment Opportunity Policy Statementand the Know Your Rights : Workplace Discrimination is Illegal Poster reaffirm this commitment. Pursuant to the San Francisco Fair Chance Ordinance we will consider for employment qualified applicants with arrest and conviction records.

    If reasonable accommodation is needed please contact our People Team at or . Ossium Health complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities.

    Principals / direct applicants only please. Recruiters please do not contact this job poster.

    Equal Opportunity Employer / Veterans / Disabled

    Key Skills

    Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

    Employment Type : Full Time

    Experience : years

    Vacancy : 1

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