Technical Operations Validation Analyst

• Create or develop engineering study developmental and performance qualification protocols for validation or requalification studies.
• Create or develop final reports of completed for validation or requalification studies.
• Planning and overall completion of scheduled validation/requalification activities
• of temperature mapping and sterilization related requalification activities independently including setup of temperature sensors and biological samples for qualification.
• Perform data analysis independently for all executed requalification and generate results
• Place data in proper scientific context by consulting and citing relevant literature.
• Understand and adhere to corporate standards regarding code of conduct safety appropriate handling of materials controlled drug and radioactive compounds GxP compliance and animal care where applicable.

Qualifications :

• Bachelors Degree in Biology Chemistry or Engineering or closely related discipline is preferred or equivalent technical experience plus demonstrated competence
• 2 years of overall experience in Validation Manufacturing Quality or Engineering preferred
• Good verbal and written communication skills
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of Steam Sterilization Autoclave Load or VHP Sterilization Validation as well as regulations and standards affecting sterility assurance preferred
• Bulk Drug or Finished goods and compounding manufacturing experience is welcomed

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our shortterm incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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