QA VALIDATION ENGINEER

Dept: Quality

Report to: Validation Team Leader

Responsibilities

To coordinate the development and maintenance of the site validation program and ensure AbbVie and external regulatory, quality, and compliance requirements are met. Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities.

• Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with AbbVie policies, FDA, European cGMP and GAMP standards.
• Generation/maintenance/execution of the Site Validation Master Plan.
• Generation/maintenance/execution of Project Validation Plans and schedules.
• Generation of validation protocols and final reports to cGMP standards.
• Generation of validation investigations and implementation of corrective actions.
• Creation/Review/Approval of various quality documents and test data.
• Management of validation, exception event, and change control processes.
• Maintenance and tracking of validation equipment, if applicable.
• Completing all required training before executing a task.
• Documenting all activities in line with cGMP requirements.
• Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
• Performing cross training within the team and training of new team members.
• Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
• Coordinating activities to maximize the effectiveness of all of the team members.
• Maintaining the overall cGMP compliance of the production areas.
• Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

Requirements

Essential Requirements

• Qualification and/or degree in engineering or scientific discipline.

Technical/Business Knowledge -Job Skills/Experience Required

• 3 years plus of knowledge of cGMP, validation and regulatory requirements relating to the biopharmaceutical industry.
• Strong communication (written and oral), presentation and troubleshooting skills required
• Effective interpersonal and organizational skills.
• Ability to work well both independently and in a team environment.
• Capable of prioritizing work and multitasking.

Cognitive Skills

• This position is crucial in identifying systems and processes requiring validation/quality assurance support and ensuring that those activities are documented, actioned, and resolved in a timely fashion.
• Good communication and motivation ability is required.

Ownership/Accountability

• Every employee has a personal responsibility to commit to the AbbVie Vision, to engage and align with the AbbVie Strategic Imperatives, and to consistently execute in accordance with the AbbVie Operational Pillars and AbbVie Ways of Work.
• This role is accountable for supporting a positive developmental culture with the organization while ensuring compliance with Quality policies.
• Requires good knowledge of Company Policies and Procedures and involves working towards general results to achieve organizational needs.
• The position has a high level of autonomy and individuals are expected to work on their own initiative.
• Demonstrates an ethos of Right First Time at all times.
• Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and ISO/FDA regulations and company policies, procedures and guidelines.
• Shows a high level of tenacity to ensure closure of issues.

Influence/Leadership

• May be required to support Cross functional teams and cost improvement projects.
• Persuasion and direction skills required to convert thinking of others where gathering acceptance is difficult but important to job performance.

Decision Making/Impact

• This position impacts manufacturing, product quality, and technical performance of the product produced at the site location.

Supervision Received

• Decision making within confines of agreed responsibility. Activities broadly defined by agreed goals and company competencies with general management oversight.

Supervision Provided

• Close contact with Personnel within the plant at all levels.
• Close contact with internal and external auditors, e.g. FDA, IMB
• Interaction with other site and TPM personnel in cross-functional Activities

EHS Responsibilities

• Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities;
• Continually be conscious of your own safety and that of others, always complying with safety notices and barriers;
• Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
• Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
• Attend all required EHS training and medical surveillance programs.
• Wear PPE as required.