Validation Manager

Validation Manager

AbbVie

Ludwigshafen, Germany

Job Description

At our Ludwigshafen site, the Validation Manager plays a key role in the introduction of new manufacturing processes and the optimization of existing ones. The role has a particular focus on melt extrusion, secondary packaging, and the assembly of autoinjectors across the full product lifecycle, including development, validation, and manufacturing in a cGMP environment.

With your experience and passion, you will work closely with a cross-functional matrix team to support technology transfers and be responsible for introducing new products into production through to validation. You will also contribute to the development and optimization of processes and procedures for the manufacture and packaging of solid dosage forms, combination products, and medical devices.

Main Responsibilities

• Support the introduction of new products through to validation.
• Track and trend product and process data, perform statistical evaluation of data, and derive appropriate actions.
• Independently prepare the annual validation master plan, including timelines, as well as templates for validation plans and reports.
• Ensure compliance with internal requirements, cGMP, and current regulatory expectations, and support the implementation of these requirements within TechOps.
• Present validation concepts and validation activities during regulatory inspections and internal audits, and represent the site in the CoE (Center of Excellence).
• Independently lead investigations of potential deviations with impact on product quality.
• Independently execute technical trials and update manufacturing and work instructions as needed.
• Support and prepare the annual Product Quality Report for all existing and future products.

Qualifications

• ​​​​​​University degree (Master’s, Diploma) in Chemistry, Biochemistry, Pharmacy, or a similar scientific discipline.
• Minimum 3 years of experience in the pharmaceutical industry, especially in secondary and primary packaging or the manufacture of solid dosage forms.
• Experience in cGMP and validation environments in accordance with Annex 15, EU GMP Guide, and 21 CFR 210/211.
• Strong experience in troubleshooting, process optimization, and scale-up of manufacturing processes.
• Very good knowledge of the manufacture, packaging, testing, and evaluation of pharmaceutical dosage forms.
• Excellent English language skills.
• High level of initiative, self-motivation, and flexibility.
• Strong leadership, communication, and teamwork skills, including in an international environment.