Cleaning Validation Specialist

4 weeks ago

Albany, New York, United States PharmaLex Full time
Job Description

PharmaLex is a leading consulting company for the Healthcare industry, offering professional development, training, competitive compensation, and a stimulating work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.

Key Responsibilities:

  • Develop and implement cleaning revalidation programs to ensure compliance with regulatory requirements.
  • Create cleaning cycle development strategies for various equipment, including process vessels, clean-in-place systems, packaging equipment, parts washers, and production facilities.
  • Write validation protocols and reports to support the site's cleaning validation program.
  • Investigate and troubleshoot problems that occur during cleaning.
  • Plan and execute onsite cleaning validation programs in compliance with regulatory requirements.
  • Prepare and review completed validation packages by compiling and analyzing validation data for submission and approval.
  • Lead the resolution of cleaning deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval.
  • Develop and author change controls for cleaning process or equipment changes.
  • Maintain an up-to-date knowledge of validation requirements, practices, and procedures.
  • Write validation plans and risk assessments related to specific projects and facilities.
  • Write and review policies and procedures (SOPs).
  • Facilitate the development of user requirement specifications and operational SOPs for equipment.
  • Perform risk assessment and gap analysis for site cleaning programs.
  • Perform cleaning studies, spray coverage testing, cleaning verification swabbing, and risk sampling.
  • Lead continuous improvement activities related to cleaning and changeover optimization.
  • Identify appropriate facility cleaning/sanitizing agents and participate in cleaning/sanitizing effectiveness studies.

Requirements:

  • Bachelor's degree in Engineering or a Scientific field.
  • 8+ years of experience in a regulated manufacturing industry, medical device, biotechnology, or pharmaceutical.
  • Demonstrated understanding and knowledge of reviewing and writing technical documents, such as risk assessments and validation documents.
  • Strong knowledge of cGMP/FDA regulations.
  • Strong communication skills (oral and written).
  • Ability to organize and manage multiple tasks in a fast-paced environment.
  • Attention to detail.
  • Demonstrated problem-solving and analytical skills.
  • Strong interpersonal skills/Team Player.
  • High degree of personal integrity.
  • Strong computer and mathematical skills.
  • Self-starter, work without close supervision.

PharmaLex is an Equal Opportunity Employer.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

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