Drug Product - Process Engineer II

  The Process Engineer II- DP Manufacturing is an integral part of the Drug Product Manufacturing Operations department, located in College Station, Texas.  This position will report directly to the Manager, DP Manufacturing.

Works independently, and with colleagues, to provide expertise and assistance in the drug product operations, including and not limited to support a flawless process execution, assisting in the writing, reviewing and approvals of change controls, deviations and CAPAS. The Engineering will be responsible to keep and maintain all equipment of the area in the operation and compliance state.

The position will focus on the resolution, improvements and enhancements of current operations which employs, Filling Isolator Technology for the aseptic filling for multiples projects. This role will also support the visual inspection process and collaborates with multiples departments to have a final DP unit, in syringes or vial presentation, complying with the quality and client standards.

This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit.  This position will also create training programs and perform training for manufacturing technicians in the unit operation categories.

The process Engineering II maybe leading/supervising others process engineering I and related technical positions for the DP team.

External US

Essential Functions:

Develop and deliver effective skills, building and training plans for a given operational technology to manufacturing technicians.

• Collaborate with individuals and teams of technicians & managers on self-development plans.
• Responsible for interfacing with internal / external technical, clients, auditors and experts and peers to maintain a broad knowledge of the technology and regulatory issues that impact the biopharmaceutical business enabling technology options to be identified, evaluated, and compared.
• Responsible for specifying, purchasing, designing, qualifying, and handing over effective manufacturing systems ensuring plant modifications have credible delivery plans.
• Take the lead in investigating and resolving events that arise from compliance issues.
• Assist in identifying improvement to and managing change of technology transfer practices to deliver continuous improvements.
• Create and maintain the technical training manuals and personnel certification process.
• Develop and assure alignment of training and skill building activities to site business requirements.
• Assure local operational practice reflect local procedure and instruction.
• Assist and Provide guidance and direction on site and cross-functional initiatives.
• Ensure supplies are in place to execute water runs and Engineering Test Plans/Studies
• Machinery- Understand technology operation capabilities, limits, and control strategies.
• Prepare statistical analysis and drive conclusions
• Review and/or Approve equipment qualification limits.
• Review Calibration Tolerances and Approve Out of Tolerance Investigations
• Coordinate validation, calibration, and PM completion of manufacturing lab equipment
• Creation and or revision of recipes or methods for various platforms.
• Represent the manufacturing unit for equipment purchase, new technology and changes to equipment.
• Assist in the transfer and scale up of new processes and technologies to the manufacturing plant ensuring requirements for EHS and cGMP compliance.
• Interface with Process Development and Process Science to ensure smooth transfer of processes into the manufacturing plant.
• Develop and approve procedures and batch records.
• Author URS (user requirement specification) documents
• Ensure best practice operating methods are deployed and assist in resolving operational problems such as deviations, QIPs, CAPAs, change controls, etc.
• Review batch records, process validation protocols, process specifications, BOMs, campaign summary reports and other documentation as needed.
• May Lead other process engineering and technical position directly and indirectly within the DP department
• All other duties as may be assigned.

Required Skills & Abilities:

• Excellent oral and written communication skills, interpersonal and organizational skills.
• Strong leadership skills.
• Ability to train others to perform to cGMP standards.
• Proficient with Microsoft Office applications.
• Good self-discipline and attention to detail; ability to work under minimal supervision.
• Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.
• Experience working in cleanroom environments under sterile or aseptic conditions; must have experience in engineering standards required for this type of operation.
• Must have good planning skills and must be willing to interface with and guide colleagues in many different roles and functions throughout the manufacturing facilities.

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, pushing, pulling, reaching above shoulders and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
• Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
• Attendance is mandatory.

Minimum Qualifications:

• Master's degree preferably in Science, Engineering, or other related field and with two (2) years of relevant experience; OR
• Bachelor's degree preferably in Science, Engineering, or other related field and with four (4) years of relevant experience; OR
• Associate degree preferably in Science, Engineering, or other related field and with sic (6) years of relevant experience; OR
• High School/GED with 8 years of relevant experience.
• All above must have one (1) year GMP experience

Preferred Qualifications:

• Experience in developing training materials.
• Experience conducting and evaluating training.
• Experience with laboratory and or manufacturing instruments/equipment.
• Previous leadership roles.

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.

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

#LI-SB2