Manufacturing Process Engineer II

Fujifilm•College Station, TX

3d•Onsite

About The Position

Summary: The Manufacturing Process Engineer II is an integral part of the Manufacturing Technical Operations department located in College Station, Texas. This position will report directly to the Manager of Technical Operations, Manufacturing. Works independently and with colleagues to provide expertise and assistance for the design, development, standardization, and maintenance of an operational biotechnology utilized to manufacture various proteins and other drug substances. This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit. Operational biotechnologies include 1. USP: Isolators and biosafety cabinets and their use in cell propagation, Cell Culture/Single Use Technology for adherent and suspension culture; 2. DSP: Dispensing and Mixing and Buffer Preparation, Chromatography, Tangential Flow Filtration, various filtration technologies, centrifugation, and Bulk Fill. This position will also create training programs and perform training for manufacturing technicians in the unit operation categories.

Requirements

Excellent oral and written communication skills and 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 –willing to work outside of normally-scheduled hours, 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 be willing to interface with and guide colleagues in many different roles and functions throughout the manufacturing facilities.
Bachelor’s degree in Science, Engineering, or other related field and two (2) years of biotech manufacturing experience; OR
Associate degree in Science, Engineering, or other related field and four (4) years of biotech manufacturing experience; OR
High School/GED with six (6) years of biotech manufacturing experience
All above must have two (2) years of GMP experience

Nice To Haves

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

Responsibilities

Develop and maintain equipment and unit operation standards and procedures utilizing the 4M (Man, Materials, Machinery, and Methods) approach
(Man) Develop and deliver practical skill-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 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.
Implement e-learning, video, classroom, and in-suite design and delivery as appropriate.
Take the lead in investigating and resolving events that arise from compliance issues.
Assist in identifying improvement to and managing change in technology transfer practices to deliver continuous improvements.
Create and maintain the technical training manuals and personnel certification process.
Develop and ensure training and skill-building activities align to site business requirements.
Assure local operational practice reflect local procedure and instruction.
Provide guidance and direction on cross-functional training initiatives.
(Materials) Understand process control and material inputs to ensure capable and acceptable process output.
Ensure supplies are in place to execute water runs and Engineering Test Plans/Studies.
(Machinery) Understand technology operation capabilities, limits, and control strategies.
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.
(Methods) Develop and maintain Technical Operational Manuals/Standard Operating Procedures/Work Instructions/Batch Records.
Lead operational technology standardization, standard batch templates, and instruction interfaces and lead continuous improvement for a given technology.
Assist in transferring and scaling new processes and technologies to the manufacturing plant, ensuring requirements for EHS and cGMP compliance.
Ensure procedures are in place to execute water runs and Engineering Test Plans/Studies
Interface with Process Development and Process Science to ensure a 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 and approve batch records, process validation protocols, process specifications, BOMs, campaign summary reports, and other documentation.
All other duties as may be assigned.