Validation Specialist I

AbbVie Inc; Worcester; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Validation Specialist I to manage validation tasks and projects, ensuring compliance with regulatory requirements. The ideal candidate will have extensive experience in manufacturing and quality, with strong communication and problem-solving skills. This position involves supervising validation efforts and working with various stakeholders to uphold quality standards in production processes. A Bachelor's degree in a relevant field is required.

Benefits

Comprehensive benefits package

Paid time off

401(k) plans

Qualifications

• 6+ years of experience in Manufacturing, Quality, or Engineering.
• Prior supervisory experience preferred.
• Knowledge of quality/compliance management related to manufacturing.

Responsibilities

• Plan and approve validation tasks.
• Maintain validation documentation.
• Supervise validation contractors.

Skills

Project management

Strong verbal and written communication

Problem solving

Analytical skills

Interpersonal skills

Education

Bachelor's Degree in Biology, Chemistry or Engineering

Job description

Company 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

The primary responsibility for the Validation Specialist I is the planning and overall approval of validation tasks. Under the direction of the Validation Section Manager, will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ key projects simultaneously. May be expected to coach/supervise contractors and/or junior Validation Specialists.

Responsibilities

• Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements.
• Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
• Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended.
• Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy.
• Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation.
• May supervise contract validation resources in the timely completion of activities in his/her area of responsibility.
• May lead, author, or review investigations and implementation of preventive and corrective action.

Qualifications

• Bachelor's Degree Required (preferably in Biology, Chemistry or Engineering).
• 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred.
• Strong verbal and written communication skills.
• Solid problem solving and analytical skills.
• Solid interpersonal skills, including ability to negotiate/influence without authority.
• Ability to supervise junior or contract team members (prior supervisory experience preferred).
• Ability to manage complex projects and multiple projects (5+) simultaneously.
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred.

Key Stakeholders

Various stakeholders within the site including but not limited to Plant Operations, Quality, Engineering/Maintenance, and Science & Technology.

Additional Information

• 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 short-term incentive programs.

Note

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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Equal Opportunity Statement

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.

Location Specific

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