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Process Validation Engineer III

4 months ago

Englewood, United States Leiters Inc Full time
Job DescriptionJob Description

Process Validation Engineer III

The Process Validation Engineer reports directly to the Manager of Validation. The role is responsible for as a SME for the Validation of cGMP manufacturing processes of sterile pharmaceutical filling for the site. This includes understanding and identifying critical quality attributes (CQAs), developing process control strategies, developing product master validation plans, and Continued Process Verification. This role may be a specialist in other topics such as Equipment Validation or Aseptic Simulation Qualification. This role ensures all processes operate within regulations to ensure the production of quality products for the Company’s 503B cGMP manufacturing facility.

Why Join Leiters Health?

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.

  • Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
  • Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
  • Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
  • Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
  • Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

Who We're Looking For:

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today

Essential Functions:

  • Process Validation Engineer III
    • Utilizes Project Management skills to plan and coordinate efforts with a cross-functional team.
    • Completes tasks in a timely fashion and communicates task status to management and/or project team.
    • Adheres to GDP/GMP guidelines to author, review, or support technical documents including but not limited to change controls, CQV protocols and reports, and CAPAs.
    • Coordination of Validation activities with stakeholders.
    • Writes and executes protocols for Validation work including highly complex systems.
    • Strategically creates and leads projects/matters. Communication may be directed towards the project team and direct management, or the audience may be a wider cross-functional group, including the Executive Leadership Team as appropriate.
    • Performs and documents Validation Gap Assessments and Risk Assessments for highly complex systems, including addressing gaps and mitigating risks.
    • Creates Validation templates for protocols and reports.
    • Creates or revises Validation Standard Operating Procedures and Job Aids.
    • Develops validation strategy in a cross-functional capacity.
    • Training and mentoring of other technical support staff (Validation Engineers, Process Engineers/Scientists, Research & Development Scientists, Project Engineers, Quality Assurance, Quality Control, etc.) on industry guidelines, expectations, and best practices for validation topics.
    • Supports the site as a specialist on complex technical and business matters.
    • Acts as a Subject Matter Expert for some or all of the following topics:
      1. Stage I Process Validation: Process Design (development of CQA/Critical Material Attributes, Process Development)
      2. Stage II Process Validation: Process Qualification (Process Control Strategy, Process Validation Master Plan, Process Performance Qualification, Mix/Hold, CCIT)
      3. Stage III Process Validation: Continued Process Verification (Monitoring and Analyzing processes through Statistical Process Control, Gap Assessments, Risk Assessments, Requalification, Change Control Assessments)
      4. Component qualification, including Filter Validation
      5. Aseptic Practices (Smoke Studies, Sterilization, Filtration of air or product, Microbiology including Endotoxin, Environmental Monitoring, and Bioburden)
      6. Aseptic Process Simulation (Media Fill Validation)
      7. Cleaning Verification and Validation (Cleaning Processes, Aseptic Cleanliness, Product Changeover)

Supervisory Responsibilities:

  • None

Experience and Necessary Skills:

  • Bachelors degree in the sciences required; i.e. chemical engineering, chemistry, or relevant industry experience.
  • Relevant experience and skillset will determine position level (I, II, or III). Recommendation is 2+ years for I, 4+ years for II, and 7+ years for III.
  • Experience considered when determining level:
    1. Experience in a highly regulated environment (preferred pharmaceutical, will consider biotechnology or related fields) including a significant exposure to regulatory requirements.
    2. Aseptic Processing
    3. Experience in project management
    4. Knowledge of regulatory and guidance documentation, such as ICH Q8(R2) Pharmaceutical Development and FDA Guidance for Industry - Process Validation: General Principles and Practices.
    5. Validation experience
    6. Statistical Analysis using software (JMP, MiniTab, Saas, etc.)
  • Strong curiosity and willingness to learn, along with the tenacity and drive to see projects through.
  • Willingness to support tasks outside normal job description, as needed. Can-do attitude
  • Advanced computer skills including proficiency in Microsoft Office (Word, Excel, Power Point).
  • Strong verbal and written communication skills with ability to communicate at all levels of the organization.
  • Ability to create technical and professional documents.
  • Strong attention to detail and accuracy.
  • Ability to multi-task, with strong organization and time-management.
  • Ability to work under pressure and independently with the ability to make decisions according to established guidelines and accomplish tasks accurately and on a timely basis.

Benefits:

  • 100% employer paid medical plan.
  • Dental & Vision insurance options including FSA & HSA
  • Employer Paid Life Insurance & Employee Assistance Program
  • Short Term & Long-Term Disability Insurance
  • Up to 4% 401K Matching (100% vested on day one)
  • Generous Paid Time Off Options – vacation, sick, paid leave and holidays
  • $5,250 Annual Tuition Reimbursement after 6 months
  • $1,000 Referral Bonus Program with no limit
  • Eligible for annual bonus program

Timeline: We will be accepting applications on and ongoing basis until position is filled.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.