Company Name:
B. Braun Medical Inc.
Approximate Salary:

Location:
Irvine, California
Country:
United States
Industry:
Healthcare
Position type:
Unspecified
Experience level:
Education level:

Sr Validation Specialist


B. Braun Medical Inc.



Requisition ID 2017-9815
Company B. Braun Medical Inc
# of Openings 1
Job Locations US-CA-Irvine
Category Quality
Position Type Regular Full-Time
Shift 8a -5p
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:

This resource will be responsible for providing validations strategy, guidance and support for Computerized/Automated systems, equipment, utilities and facilities. Support to be provided includes validations strategy definition, protocols redaction and execution, and validation protocols approval for new systems and equipment, modifications to existing systems, Capital Projects implementations, Laboratories, Cleaning Validations, R&D and Technology transfer projects.
  • Computerized systems validations to be supported includes Software, Hardware, communications and data/historian systems such as Track & Trace, Unique Device Identifier, MES, LIMS, Werum and Rockwell EBR, Wonderware Archestra and Historian, and OSI PI Historian.
  • Automated Systems Validations to be supported includes Allen Bradley PLCs, Siemens PCS and PLCs, GE PLCs, Wonderware In-Touch and Rockwell HMIs, vision systems, VFDs, communications protocols and motion controls.
  • Facility and Utilities systems to be supported/validated includes WFI, Clean Rooms, Clean Steam, and Process Qualification technical expertise. Author validation documents and execute validations of equipment control systems and computer systems..
  • Equipment validations to be supported includes Molders, Conveyors, Sterilizers, Packaging Equipment, Printers, Leak Detectors, Particle Inspection Systems, Filling and Finishing machines.

The candidate will be required to rely on experience, technical expertisse and good judgment to perform validations strategy and execution with minimal supervision.

Responsibilities: Essential Duties
  • Collaborate with Manufacturing, Engineering, IT, QA and QC to maintain the existing systems in a Validated and Compliant state.
  • Participate on internal and external audits.
  • Provide leadership/ownership for completion of validation activities required as action items from audit observations, investigations and CAPAs.
  • Establish the Validation Strategy for modifications, improvements, and Capital Projects to be implemented in the Manufacturing Areas.
  • Redaction and execution of GxP assessments, risk assessments, test protocols, IQ, OQ, PPQ, PQ, cleaning validation protocols, and traceability matrix as required for Equipment, Facilities, Utilities and Computerized/Automated systems.
  • Perform Change Control validation assessments.
  • Generate Validation Master Plans.
  • Pre-execution and post-execution revision and approval of Protocols and Summary Reports. Exception reporting and resolution approvals.
  • Support Capital Projects by overseeing the sucessful completion of validation activities including definition of validation strategy, resources, timelines for validation activities, and FAT, SAT (commissioning), IQ, OQ, PQ or PPQ, and PVs.
  • Leadership/Management of contracted resources for Validation Support.
  • Support the generation and improvement of Qualification/Validation SOPs, Templates, Forms, methods, etc.
  • Prepare, revise and/or approve equipment and computer system requirement documents, including User Requirements, Process Flow Charts, Functional Specifications and Detailed Design Specifications.
  • Contribute to the creation of Standard Operating Procedures and training materials.

Expertise: Knowledge & Skills
  • Strong knowledge of appropriate Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks.
  • Strong working knowledge in validation methodology and software development life cycle (SDLC) principles.
  • Industrial Quality Control, Quality Engineering, Quality Assurance and Validation.
  • Software packages supporting statistical data analysis, word processing, flow charting, and project management
  • Familiarity and understanding of manufacturing methods related to the production of medical devices and pharmaceuticals.
  • Familiarity and understanding of technical disciplines related to Quality Control, including Engineering and Sterilization Assurance.
  • General knowledge of computer hardware and software, including an understanding of software development.
  • Ability to work with Consultants/Contractors to achieve projects' validation objectives.
  • Ability to design, execute and analyze manufacturing process validation studies.
  • Ability to manage multiple concurrent tasks/studies.
  • Ability to execute the Validation Plans for medical device and pharmaceutical product manufacturing equipment and facilities.


Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

Required:
  • BS Degree in Engineering or Science with minimum of 10 years experience in an Validations, Technical Documentation and/or Engineering position.
  • 5+ years experience in computer system validation for equipment, facilities, and manufacturing processes in a medical device or pharmaceutical company.
  • Experience generating, executing and approving validation protocols FAT, SAT, IQ, OQ, PQs for Equipment, Facilities, Utilities, Automation and Computerized Systems.
  • Experience in Pharmaceutical and/or Medical Devices environment.
  • Must have through understanding of cGMPs, GDPs, GAMP 5, ASTM-2500, 21CFR Part 11, and other Standards and Regulations applicable to Phamaceutical and Medical Devices.
  • Proficient in using personal computers and a working knowledge of software such as MS Word, Excel and Project.
  • Good communication skills both verbal and written. Good presentation skills.
  • Flexibility to work nights, weekends and holidays as required.
  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.

Desired:
  • Integrity, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
  • Passion to innovate and drive for solutions.
  • Personal accountability for results and integrity.
  • Eagerness to learn and continuously improve.
  • Uncompromising dedication to quality.
  • Respect for individuals and the diverse contributions of all.
  • Be able to work independently and as a team member.
  • Ability to analyze, investigate and propose approaches to complicated technical issues.
  • Ability to evaluate competence of vendors to perform work within the individual's specialty(s) area.
  • Project management knowledge and skills.

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:
  • May perform other duties as assigned.
  • Might be required to travel, both domestic and international, up to 15% of the time.

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.

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