Sr. Cleaning Validation Consultant

3 weeks ago

Vega Baja PR United States PharmaLex GmbH Full time

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

General Description:

We are looking for experienced or entry-level engineering resources to provide Cleaning Validation services in Juncos PR.

Essential Duties and Responsibilities:

  • Development of a cleaning revalidation program
  • Create cleaning cycle development strategies for a variety of equipment including process vessels, clean-in-place systems, packaging equipment, parts washers, and production facilities.
  • Write validation protocols and reports in support of the site’s cleaning validation program
  • Investigate and troubleshoot problems that occur during cleaning
  • Responsible for planning and execution of onsite cleaning validation programs compliant with the regulatory requirements.
  • Prepare and review completed and executed validation packages by compiling and analyzing validation data for submittal for review and approval
  • Lead 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
  • Responsible for identifying appropriate facility cleaning/sanitizing agents; participates in cleaning/sanitizing effectiveness studies
  • Other duties as assigned

Required Qualifications:

  • Bachelor’s degree, Masters or PhD in Engineering
  • 7+ 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 communication skills (oral and written) in English and Spanish
  • 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

Job Types: Full-time, 6 months contract

Salary: From $30.00 per hour

Schedule:

  • Monday to Friday administrative shift and some non-standard shifts
  • Some weekends

Work Location: In person, Vega Baja, Puerto Rico

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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