Technical Services Engineer (Cleaning)

South Plainfield, NJ 07080

Posted: 07/24/2019 Industry: Engineering Job Number: 49300

Position Summary:

 

Responsible for all cleaning validation activities within the production facility. Will be required to support equipment qualification activities as needed.

 

Travel Requirements:  Minimal

 

Essential Duties & Responsibilities                                                                                                                             Percentage of Time

 

1.

Responsible for the development of cleaning processes for semi-solid, suppository and liquid equipment.

 

2.

Develops and executes Cleaning Development, Cleaning Verification and Cleaning Validation studies, including Clean and Dirty Hold Time Studies

 

3.

Creation of cleaning recipes for automated equipment

 

4.

Performs investigations for cleaning failures (troubleshooting) and implementation of resulting CAPAs

 

5.

Review of protocols/reports, batch records, recipes and Change Controls

 

6.

Maintains Cleaning Validation Matrix and Standard Operating Procedures associated with the Cleaning Validation Program up to date and current

 

7.

Ensure that the cleaning validation program at the site is in compliance and up to current industry standards

 

8.

Work with Supply Chain, Quality and Operations to coordinate the planning of cleaning validation/verification activities

 

9.

Perform evaluations for worst case products (risk based matrix approach) and assessment for new products being introduced to the facility (strategic).

 

10.

Perform maximum allowable carryover calculations utilizing different methodology

 

11.

Create streamlined processes for the Cleaning Validation Program

 

12.

Other projects and duties as required/assigned, including equipment qualification

 

Position Requirements

Education Required:

B.S. in Chemical Engineering or Sciences

Education Preferred

 

Experience Required:

5+ years of Hands-on Cleaning Validation experience

Experience Preferred:

5+ years of Hands-on Cleaning Validation experience, plus Qualification experience for facilities, utilities, processing/packaging  equipment

Specialized or Technical Knowledge Licenses, Certifications needed:

 

Functional Knowledge:

 

Company/Industry Related Knowledge:

 

 

Job-specific Competencies

 

Maintains confidentiality

Possesses sound analytical problem-solving and documentation skills

Demonstrates ability to prioritize conflicting demands

Executes assigned tasks within established schedules

Writes and speaks clearly and concisely

Develops and maintains expertise through continuing professional education and training

Complies with Company policies, procedures, rules and regulations

Attention to detail

Independent and possesses Leadership skills

Strong communication skills

Rebecca Levy

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