A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
Your Role: Manage and execute the Validation Program for the site. Responsible for validation of equipment and processes. Manage the Validated System Change Control Program. Supports projects required for the expansion, improvement and modernization of the production facility. Establish time lines and determine resources need to complete protocols. Implements projects within budget and schedule.
ESSENTIAL JOB FUNCTIONS
- Direct the content and structure of the Validation and Change Control program.
- Provide leadership for the content of validation projects and validation protocols.
- Lead validation projects including planning, scheduling, execution, and project communication. Provide guidance and technical information to support activities to include dry powder product processes, cleaning validation, and utility system validation.
- Proactive leadership role setting and updating site validation policies and SOPs to meet industry standards.
- Key member of multi-department teams as the Validation Subject Matter Expert (SME) bringing new products/processes on-line or troubleshooting and/or improving existing products/processes.
- Trouble shoot and direct the resolution of Validation issues by fostering effective inter-departmental and cross-functional partnerships.
- Determine validation rationale for testing of equipment, systems, and processes.
- Present and defend validation documents to customers during audits.
- Manage execution of routine validations to pre-determined schedule.
- Assess new product Cleaning and Process Validation against current database.
- Work independently to assemble protocols, and analyze test data, summarize data into final reports, and bring projects to a timely conclusion.
- Review change controls for equipment, utilities and processes and assess any effects to the validation.
- Develop validation project schedule, manage project to same, and provide routine project updates.
- Take part in and contribute to a safe working environment by following corporate and departmental safety regulations.
- Other job related duties as required.
Who You Are
- Education: B.S. Degree in Life Sciences or Engineering
- Experience: 5 - 7 years cGMP experience, preferably 3 - 5 years direct validation experience
- Skills and Knowledge:
- Sound knowledge of bioscience processes and equipment, in a cGMP environment.
- Ability to communicate clearly and professionally, both in writing and verbally.
- Strong technical and problem solving skills.
- Good project management skills.
- Expertise in the principles of validation.
- Demonstrated knowledge of the Kaye Validator and temperature data loggers.
- Good computer skills
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.