Senior Manufacturing Technician

FUJIFILM Diosynth Biotechnologies; College Station (TX); On-site; USD 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Manufacturing Technician IV to join their innovative team in a dynamic environment. This role offers the chance to work with advanced technologies in biomanufacturing, focusing on downstream processes such as filtration and chromatography. You will be responsible for writing SOPs, assisting in quality assurance, and training junior staff, all while maintaining the highest standards of safety and confidentiality. If you are detail-oriented and possess strong leadership skills, this is an exciting opportunity to make a significant impact in a growing field.

Qualifications

• Bachelor's degree or equivalent experience in relevant field required.
• 2+ years of relevant experience in a cleanroom environment preferred.

Responsibilities

• Write and review standard operating procedures and production records.
• Assist in project safety and quality assurance programs.
• Train junior team members to meet cGMP standards.

Skills

Excellent oral and written communication skills

Interpersonal skills

Organizational skills

Leadership skills

Attention to detail

Planning and time management skills

Ability to train others

Good self-discipline

Education

Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field

Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field

High School/GED

Tools

Microsoft Office applications

General production equipment (Autoclaves, Glass washers, Incubators)

Analytical Scales

pH/conductivity meters

Job description

This role, Manufacturing Technician IV, will work directly with a range of technologies. This role provides an opportunity to stay on the technical track, or work towards a supervisory path. Dependent upon assignment, the range of technologies may include any of the following:

Downstream Unit:

• Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration
• Medium to Large-scale Chromatographic systems (ÄKTA).
• Pre-Packed Columns from 1L to 100L
• Single use mixing systems (Pall & GE)
• Single Use connectivity types such as GE DAC and Colder AseptiQuik
• Bulk filling
• Aseptic process simulation and drug product filling
• Plate counting, microscopic examination
• Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation

Essential Functions Include:

• Write and review standard operating procedures, buffer formulation records and batch production records.
• Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs.
• Maintain the confidentiality of proprietary company information.
• Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.
• Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc.
• Perform daily cleaning and sanitization of the laboratory and manufacturing areas.
• Maintain an effective working relationship with others.
• Perform all other duties as assigned.

Supervisory Track Option:

• Successfully leads two or more projects at a time.
• Perform as the Subject Matter Expert (SME) on a variety of projects and range of technologies.
• Assists with onboarding new employees into the team.
• Assists Sr. Training Specialist with training needs of department.
• Responsible for maintaining the schedule and successfully coordinating with other departments.

Required Skills & Abilities:

• Excellent oral and written communication skills, interpersonal and organizational skills.
• Proficient with Microsoft Office applications.
• Excellent leadership skills.
• Ability to train others to perform to cGMP standards.
• Good self-discipline and attention to detail.
• Must be able to work flexible shifts to include weekend or night shifts, and be willing to work outside of normal scheduled hours to meet the demands of the business.
• Excellent math and computer skills.
• Experience working in a cleanroom environment with full clean room gowning and good aseptic technique.
• Must have good planning and time management skills and be willing and able to interface with 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.
• Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
• Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
• Ability to wear personal protective equipment including safety glasses, lab coat, safety shoes and gloves.
• Ability to lift/push/pull up to 25 pounds frequently and up to 50 pounds occasionally.
• Attendance is mandatory.

Minimum Qualifications:

• Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 2 years of relevant experience; OR
• Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 4 years of relevant experience; OR
• High School/GED with 6 years of relevant experience.