Manufacturing – Process Engineer II
College Station, Texas
Develop and maintain equipment and unit operation standards and procedures utilizing 4M (Man, Materials, Machinery and Methods) approach including:
(Man) Develop and deliver effective 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 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.
- 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 the transfer and scale up of 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 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.
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.
- Master’s degree preferably in Science, Engineering, or other related field and with three (3) years’ of relevant experience; OR
- Bachelor’s degree preferably in Science, Engineering, or other related field and with five (5) years’ of relevant experience;
- High School/GED with 7 years of relevant experience.
- Experience in developing training materials.
- GMP experience.
- 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 979-431-3528.