Wash and Sterilization Process Specialist

2 weeks ago

Clayton, North Carolina, United States BioSpace, Inc. Full time
About the Role

You will be joining BioSpace, Inc., a leading company in the field of bioengineering and biotechnology. The area is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The role is part of the newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across BioSpace to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. BioSpace has a global approach, where you will be working with multiple sites and cultures across the world.

Key Responsibilities

Support people, equipment, and processes for our operations areas to meet business and regulatory requirements. Support training for lower-level peers. Demonstrate subject matter expertise in assigned area. Provide process solutions for moderate to high complexity issues. Serve as a back-up as needed for the Sr Process Professional and as a mentor/coach for junior team members. Collaborate with stakeholders related to assigned area. Support training for lower-level team members. Responsible for providing in-depth deviation investigations and root cause analysis. Drive continuous improvements via Lean tools and Six Sigma methodologies and certifications. Responsible for area content and process knowledge. Identify and implement process needs and improvement opportunities for moderate to high complexity issues. Responsible for periodic reviews and reporting. Involved with collaboration across sites. Update and manage area master data and recipes as needed. Provide support on defined issues and contributes through application of expertise and knowledge. Follow all safety & environmental requirements in the performance of duties. Other accountabilities as assigned.

Requirements

Bachelor's degree (engineering, technology, or related field of study) from an accredited university required. May consider an Associate's degree (engineering, technology, or related field of study) in technology or related field of study from an accredited university with a minimum of four (4) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment. May consider a High School Diploma (GED) with a minimum of six (6) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment. Minimum of two (2) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment. Excellent written communication skills required. Thorough investigation and systematic problem-solving experience required. LEAN manufacturing experience and training required. General knowledge of change control systems and Quality Management Systems (QMS) required. Relevant electronic manufacturing system experience required (ex: SAP, PAS-X, etc.). Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train and coach others preferred. General experience with regulatory audits/inspections required. Knowledge of relevant master data preferred. Validation experience preferred. Product transfer (or tech transfer) experience a plus.

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