Sr. Specialist, Manufacturing Quality Validation

BioSpace; North Chicago (IL); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Comprehensive benefits package

Paid time off (vacation, holidays, sick)

401(k) options

Job summary

A global biopharmaceutical company in North Chicago is seeking a Sr. Specialist in Manufacturing Quality Validation. This role involves overseeing quality validation processes and managing multiple key projects. The ideal candidate will have a Bachelor's degree in a relevant field and over 6 years of experience in quality and engineering. The position offers a comprehensive benefits package and opportunities for growth.

Qualifications

• 6+ years of experience in Manufacturing and/or Packaging, Quality or Engineering.
• Experience with major validation subjects (Computer, Equipment, Cleaning, Process, etc.).
• Strong verbal and written communication skills.
• Ability to manage multiple complex projects (5+).
• Knowledge of quality/compliance management and regulations for API/Drug manufacturing.

Responsibilities

• Ensure compliance with regulatory requirements in Quality System.
• Implement and maintain Validation Master Plan.
• Manage investigations of validation failures.
• Ensure investigations of validation failures are thorough and documented and included in CAPA when required.
• Collaborate with plant/external engineering on new installations to align with cGMP and validation.
• May supervise contract validation resources to complete activities on time.
• May lead or review investigations and preventive/corrective actions.

Skills

Strong verbal and written communication skills

Solid problem solving and analytical skills

Solid interpersonal skills

Ability to manage complex projects

Knowledge of quality/compliance management

Quality/compliance management

Education

Bachelor's Degree (Biology, Chemistry, or Engineering)

Job description

Sr. Specialist, Manufacturing Quality Validation

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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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

The primary responsibility for the Quality Validation Specialist is the quality oversight and overall approval of validation and engineering change management activities. The Validation engineering department will support the implementation of the Validation quality program, and will be expected to independently manage 5+ key projects simultaneously.

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 and/or Packaging, 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 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.
• This job is eligible to participate in our long-term incentive programs.

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

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance