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[Validation Engineer] Validation Engineer

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Duties:
Lead installation and all qualification activities (IOPQ) for Purified Water (PW) Systems and Clean-In-Place (CIP) / Cleaning equipment.

Execute revalidation activities for TCU equipment (Refrigerators, Freezers, Autoclave, Incubators, Cold Rooms, Freezer Rooms)

Responsible for leading and supporting shipping validation and activities.

Lead/support the development of the process, cleaning, equipment, computer software, or facilities protocols and ensures they are in line with Validation policies and guidance documents (Liaising with equipment manufacturers, internal and external project personnel to ensure successful qualification execution).

Lead the execution of qualification protocols on the process, cleaning, equipment, computer software, or facilities as necessary.

The engineer also assists external qualification personnel with the execution of major project qualification activities which require the use of temporary external resources.

Ensure all company and Site Validation policies and procedures are adhered to.

Ensure all work carried out and equipment installed is safe, effective, and in compliance with the appropriate industry standards.

Ensure all work undertaken is reflected accurately in up-to-date Validation/project information files.

Seek and retain approval for qualification protocols from site User groups (who approve documents from a user group operations perspective) and Quality (who approve documents from a regulatory compliance standpoint).

Ensure the maintenance of a qualification document listing for all qualified equipment on site.

Ensure all qualification documentation is always maintained up to date.

Provide expert guidance for the resolution of technical issues arising during the execution of qualification activities.

Lead all validation activities for new and/or changes to labels applied to all Manufacturing products to include expertise with HF RFID systems and tags. These activities extend to adhesive and ribbon/ink changes as well.

Perform any other activities as directed by the Validation Manager.

Skills:
Strong technical expertise all aspects of qualifying Purified Water Systems, Clean-in-Place, and equipment cleaning systems and processes

Strong technical experience with qualifications in cleaning and validation.

Strong technical experience of TCU (Temperature Control Units)

Direct hands-on experience with validation of process, cleaning, equipment, computer software, or facilities.

Working knowledge of processes in purification and/or formulation required

Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required

Technical expertise in biotech unit operations, ability to handle multiple projects at one time

Strong leadership, organizational planning, and project management skills

Excellent interpersonal effectiveness and communication skills (written and oral)

Ability to work with a cross-functional team to achieve expected results

Expertise in leading validation activities for labeling and HF RFID systems is helpful as well as label ribbon/ink label validation activities

Proficient in MS Word, Excel, and Project

Occupational Demands:

Ability to lift 20-30 lbs. and stand for an extended period of time.

Education:
Bachelor's Degree in Engineering or Science discipline, an advanced degree is a plus.

Years of Experience:

Minimum 5+ years of relevant validation experience in a regulated industry


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