[ref. i34749802] Senior Lab Engineering Specialist

Overview:

Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FDB call Genki.

Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

In addition, this position is a major contributor to implementation of new technology and equipment life cycle monitoring.

Additional responsibilities include supporting the design, procurement, installation, and start-up of new analytical equipment in accordance with FDBT standards and cGMP regulatory requirements. This position may require support outside of normal business hours.

Additionally, a basic understanding of PC troubleshooting, networking, and Microsoft Active Directory is a plus.

• External US:

Essential Functions:

• Support validation protocols execution.
• Provide hands-on and effective diagnostics/troubleshooting functions
• Support the design and implementation of sound engineering solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with FDBT standards and cGMP regulatory requirements
• Provide laboratory engineering support for capital projects concurrently with a dynamic workload based upon site priorities
• Troubleshoot technological issues and solve problems quickly to ensure our business operations run smoothly.
• Review technical equipment operating manuals for recommending routine maintenance, calibration, spare parts, and other systems as needed.
• Act as a subject matter expert for the development of engineering and validation documents, i.e., User Requirement Specification, Functional Specification, Design Specifications, and Guidelines for new and existing analytical/process equipment systems.
• Develop, mentor, and train coworkers as well as peers on analytical equipment functionality, troubleshooting, and diagnostic techniques to enhance the overall capability of the organization.
• Develop and revise laboratory engineering SOPs.
• Support investigations to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence.
• Interface and build collaborative partnerships with key site functions including Manufacturing, Analytical and Process Development, Technical Operations, Engineering, and Quality to deliver site goals and objectives.
• Lead tasks with minimal or no guidance and supervision.
• Interface with IT to ensure GMP and GLP compliant integrations.
• Prepare, assist, and participate in system, specification development, and design.
• Support data integrity initiatives.
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulations, and industry codes.
• Actively manage contractor activities to ensure work quality and safe practices to facilitation of contractor training
• Other duties as assigned.

Preferred Skills & Abilities:

• Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC).
• Good understanding of cGMP industry standards for analytical test equipment, systems quality test requirements, and 21 CFR Part 11.
• Understands change control and CAPA.
• Effective organizational, verbal, and written communication skills with the ability to effectively communicate within cross-functional teams and to management.
• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
• Desire to work in fast-paced, state of the art, research and customized manufacturing facility.
• Proficient computer skills with experience using Windows based operating systems with an understanding of installing, configuring, testing, and maintaining operating systems, application software and system management tools.
• Strong technical aptitude for problem solving and data driven decision making.
• Basic understanding of site initiatives and the impact on regulatory guidelines.
• Experience with analytical methods supporting biopharmaceutical processing.
• Excellent interpersonal skills and be able to work effectively and efficiently in a team-based environment.
• Maintains effective relationships across functional units gaining their trust and respect.
• Openly shares knowledge/information needed to accomplish a task or solve a problem.
• Exhibits professionalism and sets an example for others to follow.
• Self-starter and detail oriented.
• Ability to manage commitments while displaying an eagerness to learn and continuously improve.
• Effective presentation skills with the ability to clearly articulate sound reasoning and data for recommended courses of action.
• Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-technical personnel

Working Conditions & Physical Requirements:

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. While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
• Working on ladders.
• Be exposed to noisy environments.
• Attendance is mandatory.

Minimum Qualifications:

• Bachelor’s Degree in Science or Technical discipline with a minimum of seven (7) years’ relevant technical experience; OR
• Associates Degree and nine (9) years’ relevant technical experience; OR
• High School Diploma or GED and eleven (11) years’ relevant experience.
• Must include a minimum of five (5) years in the bio-pharmaceutical industry in a role requiring hands on experience with analytical/process equipment covering Quality Control and Process Development organizations.

Preferred Qualifications:

• Master’s Degree in a Science or Technical discipline.
• A+ Certification or equivalent training is a plus.

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.

If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3500.

In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.