cGMP Manager - Geismar, LA-1805468 We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, age, citizenship, color, religion, sex, marital status, national origin, disability status, gender identity or expression, protected veteran status, or any other characteristic protected by law.
At BASF , we create chemistry through the power of connected minds. By balancing economic success with environmental protection and social responsibility, we are building a more sustainable future through chemistry. As the world's leading chemical company, we help our customers in nearly every industry meet the current and future needs of society through science and innovation.
We provide a challenging and rewarding work environment with a strong emphasis on process safety, as well as the safety of our employees and the communities where we operate. We are always working to form the best team—especially from within, through an emphasis on lifelong learning and development.
And we are constantly striving to become an even better place to work. BASF has been recognized by Forbes Magazine as one of America's Best Employers in 2017. Come join us on our journey to create solutions for a sustainable future!
cGMP Manager (1805468) – Geismar, LA
Where the Chemistry Happens
We are seeking a professional like you to lead and maintain the validated state of cGMP (current Good Manufacturing Practices) equipment, systems and processes as required by the US Food and Drug Administration (FDA) at BASF manufacturing, tolling, and storage facilities. In this role you will be responsible for the implementation and maintenance of Equipment, Software, Utilities, Cleaning and Process Validations, process capability studies and process improvements.
You will also support process development and design transfer activities, including, but not limited to process mapping, operational procedures, inspection plans, MSA/gauge R&R studies, and training. You will aid in new product scale-up, process optimization, and technology transfer, as well as provide support during regulatory inspections and customer audits. This will lead to identifying and implementing quality system improvements when gaps are identified through audits and departmental reviews.
This position supports all of NA for Care Chemicals (N-EMN) and Pharma/Nutrition (N-ENN) operations.
Qualifications - BASF recognizes institutions of Higher Education which are accredited by the Council for Higher Education Accreditation or equivalent
Formula for Success
· Your proven experience in maintaining a validated state in manufacturing, tolling and storage facilities will be essential as you will be responsible for the planning, execution, and lifecycle maintenance of validation programs and oversee all phases of validation.
· Leveraging your education in Engineering, Chemistry, or a scientific discipline combined with your progressive experience in qualification / validation in a Pharmaceutical or Life Sciences regulated industry, you will develop/write/execute/coordinate IQ, OQ, PQ, CV, PV and Engineering trial protocols for simple and complex manufacturing processes and their respective equipment, including utilities, software, and hardware.
· Successfully engaging across the organization, you will work with QA, Regulatory, Manufacturing, and Process/Analytical Development to generate Risk Assessments and determine documentation for validation programs through all phases of product/process development, technology transfer and ultimately commercial manufacturing. Additionally, you will work cooperatively with all business functional groups to promote current knowledge and awareness of pharmaceutical cGMPs, industry trends and guidance documents issued by various national and international regulatory agencies.
· Demonstrating your experience working in a cGMP environment and knowledge of ICH Q7, Q8, Q9, Q10 and FDA, ISO and cGMP regulations, you will generate and resolve protocol discrepancies and/or deviations that may arise as part of validation execution, as well as overall cGMP compliance.
· As a subject matter expert, you will provide validation and cGMP training to Production Specialists, Production Engineers, Managers/Supervisors and Unit Operators. You will also work with the LDC (Learning and Development Coordinator) to ensure training is achieved to the expected competency for FDA regulated manufacturing processes and storage facilities.
· Your strong teamwork and collaboration mindset will be vital as you actively lead and participate i n cross-functional teams and lead project initiatives to ensure projects are delivered on time and to required quality standards.
· Your excellent technical writing, document control, verbal communication and organizational skills will be necessary as you communicate validation requirements, timelines, and resource needs to senior management, review and approve operating procedures, change controls (MOCs), and non-conformances (NCMs) that may impact validation and applicable manufacturing documents necessary for process performance, and draft and complete Final Reports and/or Closure Reports for validation documents.
· Your proficiency in the use of risk-based approach to validation (FMEA, PHA, etc.) will be important as you lead validation consultants / contractors as necessary to complete assigned tasks.
Create Your Own Chemistry: What We Offer You
Adding value to our customers begins with adding value to you. You@BASF is the suite of benefits, perks, programs and unique opportunities we offer to support you—the whole you—in all stages of your life and career. With you@BASF, you create your own chemistry.
The total rewards that you receive as a BASF employee go way beyond a paycheck. From competitive health and insurance plans, to robust retirement benefits that include company-matching contributions, to making sure you never stop learning, we believe investing in you is investing in our success. Working for a large, global organization, you'll have a chance to grow professionally and personally, expand your network and build a rewarding and dynamic career.
BASF provides interesting and challenging learning and development opportunities to help you make the most of your talents and your job.
This position requires all candidates to either currently possess or obtain and maintain a TWIC (Transportation Worker Identification Credential) Card from the U. S. Department of Homeland Security.
At BASF, we create chemistry – and have been doing so for 150 years. Our portfolio ranges from chemicals, plastics, performance products and crop protection products to oil and gas. As the world’s leading chemical company, we combine economic success with environmental protection and social responsibility. Through science and innovation, we enable our customers in nearly every industry to meet the current and future needs of society. Our products and solutions contribute to conserving resources, ensuring nutrition and improving quality of life. We have summed up this contribution in our corporate purpose: We create chemistry for a sustainable future.