Validation Specialist at Abbott

Hangzhou, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Medical DevicesIndustries

Requirements

Bachelor's Degree (±16 years) or Master's Degree (±18 years)
Minimum 2-5 years of related work experience with a good understanding of specified functional area
Working technical knowledge and application of concepts, practices, and procedures
General understanding of business unit/group function
Ability to perform in a quality system environment, with awareness that failure to perform tasks can result in noncompliance with governmental regulations
Ability to work on problems of moderate scope, analyzing situations or data requiring review of identifiable factors
Exercises judgment within defined procedures and practices to determine appropriate action
Broad knowledge of technical alternatives and understanding of their impact on the systems environment

Responsibilities

Represent Abbott Division during internal and external audits of validation projects and documentation
Write validation documentation against production processes and systems in compliance with internal and external requirements utilizing well-developed technical and regulatory skills
Manage the execution of validation protocols as protocol directors to ensure timely and cost-efficient completion through specialized experience and training
Evaluate validation results of validation protocol executions employing specialized experience and training
Consult with owner/user groups to summarize validation results in final reports incorporating strong communication skills and experience
Manage Validation Master Plans (VMPs) and associated reports related to new product development and existing production processes, systems, and controls
Perform validation assessment on Change Management documentation including document changes, system changes, and process changes
Track and report validation progress of corporate validation projects through departmental project tracking tools
Cultivate a wide range of internal networks and develop an extensive external network of resources to facilitate completion of tasks
May lead a project team of moderate scope
Provide guidance to less experienced staff and act as a mentor to lower level individual contributors
Influence at peer level and occasionally at first levels of management
Plan, organize, and prioritize own daily work routine to meet established schedule
Exercise authority and judgment within defined limits to determine appropriate action

Skills

Key technologies and capabilities for this role

Validation ProtocolsValidation Master PlansChange ManagementQuality SystemsRegulatory ComplianceInternal AuditsExternal AuditsProject ManagementTechnical WritingProcess Validation

Questions & Answers

Common questions about this position

What education and experience are required for the Validation Specialist role?

A Bachelor's Degree (16 years) or Master's Degree (18 years) is required, along with a minimum of 2 years of related work experience, ideally 2-5 years with a good understanding of the functional area.

Is the salary or compensation specified for this position?

This information is not specified in the job description.

What is the work arrangement or location policy for this role?

This information is not specified in the job description.

What are the main responsibilities that highlight key skills needed?

Key skills include writing validation documentation using technical and regulatory knowledge, managing validation protocols and master plans, evaluating results, and strong communication for reports and audits.

What makes a strong candidate for this Validation Specialist position?

Strong candidates have 2-5 years of experience, technical knowledge of validation in quality systems, regulatory skills, ability to lead projects and mentor staff, and judgment within defined procedures.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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