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Cleaning Validation Engineer

4 months ago

Mooresville, United States BestCo Full time

** Cleaning Validation Engineer**

**Job Category****:** Quality & Reg Affairs **Requisition Number****:** CLEAN001890 Showing 1 location **Job Details**

**Description**

**BestCo Inc**. is a privately-held manufacturer located and operated in Mooresville, North Carolina. **BestCo** is known industry-wide as a leading developer and marketer of innovative, consumer health care products for retailers and marketers of OTC drug products and dietary supplements. **BestCo** specializes in manufacturing solid dose lozenges, soft chews, and other confectionery-based delivery forms of consumer healthcare products for both private label and contract manufacturing partners. **BestCo** combines nearly a centurys worth of confectionery experience with emerging consumer healthcare insights to create unique products for our customers. **BestCo** strives to be a pioneer and innovator in the field of confectionery delivery forms of OTC drugs and dietary supplements.

**BestCo is currently searching for a Cleaning Validation Engineer to be located at our Mooresville, North Carolina facility.**

**POSITION SUMMARY**: Under the supervision of the Director of Regulatory Affairs and Quality Control, the Cleaning Validation Engineer is responsible for the sites equipment cleaning validation program.

**ESSENTIAL DUTIES AND RESPONSIBILITIES:**

* Development and maintenance of 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 sites validation program

* Investigate and troubleshoot problems which occur during cleaning

* Responsible for planning and execution of onsite cleaning validation programs compliant with USFDA 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

* Develops and authors change controls for cleaning process or equipment changes

* Write and execute IQ/OQ/PQ/ and cycle development protocols including development of final reports.

* 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.

* Leads continuous improvement activities related to cleaning and changeover optimization

* Responsible for identify appropriate facility cleaning/sanitizing agents; participates in cleaning/sanitizing effectiveness studies

* Other duties as assigned

**Supervisory Responsibility:**

This position is an individual contributor role.

**Knowledge and Skill Requirements:**

* Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, IOQ protocols and final reports

* Hands-on experience supporting/executing IQ, OQ (IOQ) equipment qualification related to various cleaning processes and activities

* Thorough knowledge of cGMP/FDA regulations

* Ability to drive change and motivate others toward a common vision

* Ability to constructively challenge cross-functional project teams and business partners to achieve project goals.

* Demonstrated facilitation, problem solving, and analytical skills

* Understanding of cGMP regulation and quality management systems for pharmaceutical operations

* Strong communication and presentation skills, both oral and written with a demonstrated ability to present key quality/department/business indicators to both first-line staff and senior management

* Strong interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills

* Must have strong ability to organize and manage multiple tasks in a fast-paced environment.

* Team player

**REQUIRED QUALIFICATIONS:**

* Bachelor's degree

* 2+ years of Cleaning Validation experience

**PREFERRED QUALIFICATIONS:**

* Bachelors or Master's degree in Engineering or Science

* More than 2 years of Cleaning Validation experience in an FDA 21 CFR regulated industry

***"NO OUTSIDE RECRUITING AGENCIES"***

All offers of employment are conditioned upon the successful completion of a background investigation, drug screen, and employment eligibility verification (E-verify).

BestCo is an Equal Employment Opportunity/Affirmative Action Employer

Minority/Female/Disability/Veteran **Skills**

**Ability to Make an Impact****:** Inspired to perform well by the ability to contribute to the success of a project or the organization **Education**

**Preferred**

Bachelors or better.

**Experience**

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)