The Validation Engineer II is responsible for cleaning validation plans, ensuring compliance with GMP standards, generating protocols, and coordinating validation activities in API and Biologics manufacturing facilities.
Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job DescriptionPurpose:
- Responsible for adhering to Cleaning Validation Master Plans and strategies for initial and periodic re-validation.
- Responsible for ensuring risk based cleaning validation policies and standards have robust quality oversight and are in compliance to GMP standards and AbbVie policies and procedures.
Major Responsibilities:
- Adhere to appropriate validation master plans, validation execution plans, and procedures related to risk based cleaning validation of equipment and processes in the AbbVie Operations Campus in Tuas, Singapore comprising of both API and Biologics manufacturing facilities.
- Generate, execute, and review protocols for initial and subsequent re-qualification programs related to cleaning verification / validation to ensure equipment and cleaning processes are maintained in a validated state.
- Support the development of specifications and strategies for equipment and processes from a cleanability perspective to ensure equipment qualification and maintenance is in line with the cleaning strategy.
- Coordinate risk based cleaning validation activities and actively ensure flawless execution of protocols and procedures.
- Support the Subject Matter Expert (SME) for risk based cleaning validation topics related to both the BIO and API cleaning processes – including topics related to associated deviations, change management, investigations, CAPA identification and closure.
- Responsible to analyze trends, identify and resolve issues that potentially impact validated status of cleaning processes.
- Implement an efficient triaging system that will provide optimal guidance to Manufacturing personnel on issues encountered during routine manufacturing. In addition, provide support to Operations & Maintenance (O&M) personnel on cleaning challenges and issues.
- Work with cross functional teams in providing quality oversight related to cleaning validation related procedures and ensure compliance to GMP standards and AbbVie policies and procedures.
- Adhere to continually evolving GMP regulations and industry practices with particular relevance to cleaning validation and contribute to the implementation of plans to address any gaps.
- May collaborate with other AbbVie sites within the network as required to ensure a harmonized approach to Risk Based Cleaning Validation.
- Support on topics related to cleaning validation during inspections and audits.
Education
- Degree or higher in Science or Engineering or Pharmacy discipline with at least 3 years of relevant work experience
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
Job/ Technical Skills
- Knowledge of pharmaceutical regulatory requirements (GMP) is essential.
- Working experience and knowledge of Risk Based Cleaning Validation Lifecycle for start-ups and brownfield projects is a plus.
- Hands-on experience in establishment and maintenance of Equipment Qualification supporting cleaning activity is a plus.
Business Skills
- Good communication skills.
- Leadership skills is a plus.
- Excellent team player willing to work for the common goal.
- Demonstrates the highest levels of integrity and a strong work ethic at all times.
- Is results driven striving to meet all targets and metrics as set by department/site and company leaders.
- Ability to communicate upwards and cross functionally to ensure all key project milestones are met is a plus.
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.html
AbbVie Singapore, Singapore, SGP Office
9 North Buona Vista Drive, Singapore, Singapore, Singapore, 138588
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