Validation Expert Jobs

Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine.

Advanced Accelerator Applications offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

Location: On-site

The Validation Expert is responsible for completing and managing process, primary packaging, and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations.
Stewardship:

• Support Product Steward in maintaining the process control strategy. Translate applicable process parameters and the process control strategy into a focused validation plan for process validation.
• Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).

Validation:

• Reviews Master Batch Records and associated change controls. Confirm revalidation need based on technical changes
• Provides technical expertise (and may facilitate) pre-validation risk assessments using risk management tools. Work collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented.
• Support validation lead for important metric reporting.
• Support execution of validation activities at the shop floor.
• Author and review process, packaging or cleaning validation protocols & reports, ongoing process and cleaning verification protocols & reports.
• Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV). Ensure that appropriate variables are identified for on-going monitoring as a contributor to quality risk management activities.
• Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence.
• Support site validation planning by writing and maintaining master plans for processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable).
• Maintain all activities and projects under own responsibility in an inspection ready status.

Launch & Transfer:

• Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation.
• Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready

Training:

• Own the Training Curriculum for own Job Profile.

The pay range for this position at commencement of employment is expected to be between $92,800 and $139,200 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Operations

Radio Ligand Therapy

USA

Indianapolis, IN

AAA USA Inc.

Technical Operations

Full Time

Regular

No

Yes