Description

ICompany Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose Statement:

• Ensures appropriate policies and standards are applied and that engineering activities have
• robust quality oversight.
• Responsible for adhering to Validation Plans for Process Equipment, Facility and Utility, Lab equipment and Shipping Validation for initial and periodic evaluation.
• Coordinate validation activities actively, ensure flawless execution of protocols and procedures
• Support on topics related to Qualification during inspections and audits
• Responsible to analyze trends, identify and resolve issues that potentially impact validated status of E/F/U systems.

Responsibilities:

• Adhere to Validation plan and procedure related to E/F/U systems Qualification, Lab
• equipment Qualification and shipping Validation.
• Adhere to continually evolving GMP regulations and industry practices with particular
• relevance to qualification of E/F/U systems, lab equipment and shipping validation and
• contribute to the implementation of plans to address any gaps
• Adhere to appropriate validation master plans and validation execution plans related to E/F/U
• system, Lab equipment and Shipping validation in the AbbVie Operations Campus in Tuas,
• Singapore comprising of both API and Biologics manufacturing facilities.
• Generate and execute protocols for initial and subsequent re-qualification programs related to
• E/F/U systems, Lab system and Shipping validation.
• Work with cross functional team in providing Quality oversight in E/F/U and lab equipment
• Qualification related procedure and ensure compliance to GMP standards and AbbVie policies and procedures
• Actively engaged in developing specifications for E/F/U systems and assist in Commissioning
• (FAT / SAT etc., not limited) of related system as part of the new build-outs
• Collaborate with other AbbVie sites within the network to ensure a harmonized approach to Qualification.
• Act as one of the key focal points for Qualification and Validation (E/F/U, Lab equipment &
• Shipping validation) topics such as deviations, change management, investigations, CAPA identification and closure and as a Subject Matter Expert, front regulatory audits, whenneeded.

Qualifications

• Degree or higher in Science or Engineering or Pharmacy discipline with at least 3 years of relevant work experience
• Working experience and knowledge on Commissioning and Qualification of start-ups and brownfield project experience is a plus
• Hands-on experience in establishment and maintenance of Shipping Validation is a plus.
• Good leadership and communication skills
• Excellent team player willing to work for the common goal
• Knowledge of pharmaceutical regulatory requirements (GMP) is essential
• Must become familiar quickly with products and processes in order to assess quality issues.
• Shows a high level of tenacity to ensure closure of issues.
• Largely self-managed with ability to communicate upwards and cross functionally to ensure all key project milestones are met

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.htmlI