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Manager Validations Servicescontact HARLAN Staffing
Job Description:


Oversee and lead the implementation and validation of production equipment and processes used in

cellular manufacturing as part of company's global CMO business. Lead a team of Validation Associates to establish and maintain a validated state of cell based manufacturing and coordinate technology transfer to/from other sites as needed. Support manufacturing to satisfy the quality and process validation requirements for existing products in a rapid growth environment as well as participate in the development and validation of new products, as needed. Also serve as a technical resource to improve product quality, reliability, and process capability. 

1. Assess new and existing processes (including Equipment PQ, Process and Cleaning Validation,

etc.) against cGMP requirements for process validation and determine when re‐validation is


2. Develop and implement strategy for equipment IQ/OQ/PQ, process validation, test method

validation, and spreadsheet validation.

3. Perform functional and process risk assessments in conjunction with Quality and Operations

subject matter experts.

4. Oversee development and execution of validation protocols and review objective evidence for

inclusion in validation reports.

5. Manage documentation and resolution of deviances and variances that occur during validation.





1. Bachelors, Masters, or Ph.D. in Biochemistry, Biology or related science field

2. At least 8 years experience in the biotech/pharmaceutical industry in validation, quality

management, process controls, and continuous improvement in an FDA‐regulated environment.

3. Demonstrated knowledge and application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC

standards, and 21 CFR Part 11 in a manufacturing setting.

4. Demonstrated application of FMEA, Risk Analysis, Validation principles, guidelines and industry

best practice.

5. Ability to multi‐task and methodically manage projects in a fast‐paced manufacturing


6. Demonstrated history of team management and effecting cross‐functional change with strong

analytical problem solving and interpersonal skills.


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