B. Braun

  • Senior Validation Manager

    Job Locations US-CA-Irvine
    Requisition ID
    2017-10610
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Quality
    Position Type
    Regular Full-Time
    Shift
    8:00am- 5:00pm
    Site
    Irvine, CA
  • Overview

    With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

     

    U.S. Facilities and Operations:

     

    Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.

    Responsibilities

    Position Summary:

     

    Lead the daily operations of the Validation Team, including validation contractors, in support of 24-7 manufacturing of pharmaceutical products. Develop and execute efficient validation strategies that meet regulatory requirements and industry standards.  Manage all aspects of the validation lifecycle to assure facilities, utilities, equipment and processes operate in a state of control and consistently and reliably produce products that conform to specifications.  Ensure changes in quality and regulatory compliance requirements are identified, documented, integrated, and maintained.

     

    Responsibilities: Essential Duties

     

    • Manage the site validation program for existing and new products, manufacturing processes, testing, packaging, shipping, facilities and utilities. Ensures continued compliance to current regulatory requirements (CGMPS), industry standards and corporate policies and procedures. 
    • Collaborate with Engineering and Manufacturing functions to assure that equipment and process specifications and requirements are documented. These may include but are not limited to User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and equipment and process Failure Mode and Effects Analysis (FMEA).
    • Maintain oversight of team that reviews and approves GXP Assessments for facilities, utilities, manufacturing equipment, and computerized systems, applications and components to define the collective requirements for validation.
    • Provides direction and participates in validation protocol development/review and approval. Assure that validation prerequisites have been properly conducted prior to validation execution,  This includes but may not be limited to design of experiments (DOE) to define critical process parameters (CPPs) and operating ranges that support repeatable and reliable execution of the system’s intended function.
    • Oversees and participates in the review of technical data generated during validation execution to assure that accurate conclusions. Reviews and approves validation and test reports to adequacy and completeness.
    • Collaborate with other Quality departments and Manufacturing to implement product monitoring activities that provide ongoing assurance that the systems continue to produce products that conform to specification. Participate in annual product reviews to identify revalidation needs.
    • Accountable for maintaining the Site Master Validation Plan and inventory of all site validations.
    • Lead team that assesses GMP changes to assure that the validated state and process control is maintained.
    • Ensure appropriate staffing of team with validation subject matter experts. Provide ongoing coaching and mentoring to assure that team’s competency remains current with changes in regulatory requirements and industry standards.  Assure consistent execution across the team to standardize approaches to validation that are efficient, effective and compliant.  Provide training for other functions, as required, on validation requirements.   
    • Interfaces with Regulatory agencies, as required, in conjunction with new drug applications, facility inspections, and technical interchanges to represent the company position with respect to validation.

    Expertise: Knowledge & Skills

    • Knowledge of current Good Manufacturing Practices, Validation Systems, Procedures, and best practices, and overall Federal Regulatory requirements and guidelines.
    • Managerial/supervisory experience. Must have excellent interpersonal and communication skills and be able to effectively work with a wide variety of disciplines and all levels of management.
    • Must have experience in effective project management and proven leadership skills.

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc

     

    Required:

    • Bachelor's Degree or higher in Biomedical or Chemical or Mechanical or Industrial Engineering or an equivalent Science/technical field.
    • A minimum of 10 years of experience in a regulated industry [medical device, pharmaceutical, automotive, aerospace or equivalent]. Experience with manufacturing of large volume parenterals is preferred.
    • Minimum of 5 years of managerial experience.
    • Travel to any B. Braun facility domestic and international.

    Desired:

    • Knowledge of ICH Q9 Quality Risk Management and GAMP is strongly desired. 

     

    While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

     

     

     

    Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com Equal Opportunity Employer Minorities /Women/ Veterans/Disabled

     

    Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. 

    Other

    Responsibilities: Other Duties:

     

    The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

     

    Physical Demands:

     

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    Work Environment:

     

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

     

    IN2017

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