Sr Manager, Microbiological Quality & Sterility Pomezia

Sr Manager, Microbiological Quality & Sterility
Pomezia
Lazio, Pomezia

Johnson & Johnson is currently recruiting a Senior Manager, Microbiological Quality and Sterility Assurance (EMEA).

This position will be located in High Wycombe, England; Val De Reuil, France; Wuppertal, Denmark; Mandra, Greece; Pratica di Mare, Italy; Spain; or Norrbroplatsen, Sweden.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years.

We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.

With $82. 1 billion in 2020 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets.

Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.

Proud to be an equal opportunity employer.

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day.

Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

The Senior Manager of Microbiological Quality and Sterility Assurance will be responsible for implementing policies, procedures in the areas of microbiological quality and sterility assurance for new products, lifecycle management, and issue resolution for NCHC in the Europe, Middle East and Africa (EMEA) region.

**Microbiological Quality and Sterility Assurance responsibilities**:

- Lead and perform Microbiological Quality and Sterility Assurance practices in the EMEA region, and aid with other regions as needed

- Lead and perform duties to support the validation and maintenance of the aseptic and/or sterilization processes used in the region, and prepare protocols and technical reports

- Support internal and external manufacturing to ensure microbiological practices are at the appropriate level for the product being manufactured (e. g. , microbiological limits appropriate for label claims, release criteria and sampling strategies, and aseptic/terminal sterilization processes utilized) with an end-to-end mindset

- Lead and/or support the investigations of process deviations and out of specifications, including CAPA management under regional quality management systems

- Conduct training for manufacturing, laboratory, and management personnel, as needed, to support the implementation of microbiological quality and sterility assurance practices

- Support internal and external manufacturing audit assessments to include suppliers (e. g. , manufacturing of raw materials/components, contract labs, contract sterilization)

- Provide microbiology and sterility assurance expertise for new product development and lifecycle management changes

- Provide due diligence support for acquisitions and integration

- Liaison to regional industry and/or standards organizations

**Qualifications** Position Requirements

- Minimum of a Bachelor's degree (BS/BA) in Microbiology, Biology or related discipline.

- Minimum of 8 to 10 years of experience in microbiology and/or sterility assurance roles

- Demonstrated competency in a minimum of two (2) modes of sterilization (e. g. , EO, radiation (gamma, electron beam), moist heat, dry heat) is required with a competency in aseptic and/or hygienic microbiological practices in a manufacturing environment desired.

- Experience in trouble shooting microbiological and/or sterilization process non-conformances and out of specification test results, and providing robust resolutions

- The individual needs to be a self-starting results-oriented individual with the ability to work independently while also being a productive contributing team player.

- Experience working in a regulated industry, preferably over-the-counter products, cosmetics, supplements and/or medical devices.

- Possesses regional and collaborative mindset

**Preferred Requirements/Competencies

- Advanced level degree (MS or PhD)

- Hands on experience in the operations of a microbiology laboratory conducting testing to support microbiological quality or sterility assurance testing and/or previous experience in the operations of terminal sterilization processes

- Strong ability to explain technical issues to individuals not in this technical field

- Strong presentation skills

- Ability to simultaneously work on multiple initiatives

- Strong project management skills

- Ability to develop strong relationships with internal and external partners

**Primary Location

Fran