DS Manufacturing Associate IV/V
Company: FUJIFILM Diosynth Biotechnologies
Location: Holly Springs
Posted on: November 24, 2022
The Drug Substance Manufacturing Associate during the project
phase is responsible for activities associated with factory
acceptance testing (FAT), commissioning, qualification, and
validation (CQV) of drug substance process equipment. During the
project phase, and as CQV activities allow, create and/or review of
manufacturing work instruction or procedures or other manufacturing
operational readiness tasks will be required. Travel will be
required. At project completion, the associate would transition
into manufacturing operations as a manufacturing associate in Drug
Substance Manufacturing (DSM) Cell Culture or Purification areas
requiring shift work (nights and weekends). External US Job
- Support Factory Acceptance Testing (FAT) at the vendor site.
Can include international travel.
- During the project FAT phase, in the initial year, 50%-75%
travel may be required.
- During site CQV activities, working on shift (nights and
weekends) may be required.
- Support Site acceptance, IQ, OQ, and PQ testing.
- Generate Testing protocol instances based on approved
- Draft and review operational standard operating procedures and
work instructions for the operation of production equipment.
- Perform other operational readiness tasks for the DSM
organization as CQV activities allow.
- Mentor junior manufacturing associates on technical and
- Provide technical and operational input related to the start-up
of the DSM facility.Operational Phase
- Lead production activities within DSM manufacturing.
- May act as deputy to the area supervisor.
- Execution and GMP manufacturing activities using an electronic
batch record, Standard Operating Procedures, and work
- Revision of cGMP documents.
- Document Deviations and support investigations.
- In-process measurements and aseptic sampling.
- Execution of validation protocols.
- Perform Material Transactions in SAP.Preferred Requirements
- Basic math add, subtract, multiply, divide, fractions, percent
- Basic conversational and written English.
- Must have excellent work ethics, personal responsibility,
initiative and teamwork.
- Must have excellent hand-eye coordination, manual dexterity and
- Must effectively communicate and have the ability to read and
comprehend manufacturing drawings and assembly, operating and
material handling procedures.
- Must pay excellent attention to detail and quality requiring
- Must be comfortable with computers to access information,
navigate on-line and run custom computer programs.
- Flexible to work productively in a team-oriented environment
under limited supervision.
- BA/BS Degree (any area of study) or Related work experience 4-8
yearsMental & Emotional Requirements
- Resilience - Adapting well in the face of workplace stressors,
the ability to work effectively and efficiently in high stress and
conflict situations, the ability to remain poised under all
circumstances, the ability to maintain regular attendance and be
- Communication - The ability to successfully and professionally
express and exchange ideas and meanings with all levels of
employees in the organization, the ability to interact
appropriately with a variety of individuals including
customers/clients, the ability to work as an integral part of a
team, ability to interact effectively with people in a positive
manner that engenders confidence and trust.
- Reasoning and decision-making - The ability to understand,
remember and follow verbal and written instructions, the ability to
reason logically and make sound decisions.
- Comprehension - The ability to complete tasks without direct
supervision, the ability to simultaneously address multiple
- Organizational skills - Ability to multitask without loss of
efficiency or accuracy, the ability to work and sustain attention
with distractions and interruptions, the ability to perform in
situations requiring speed, deadlines or productivity
quotas.Working Conditions & Physical RequirementsThe 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
- Experience prolonged sitting, standing, walking, bending,
stooping and stretching throughout the shift, up to 12 hours.
- Use hand-eye coordination and manual dexterity sufficient to
operate a computer keyboard, telephone, calculator, and other
office equipment is required.
- Have a normal range of vision.
- May be required to lift up to 50 pounds on occasion.
- Climb ladders and stairs of various heights.
- Be exposed to wet or humid conditions.
- This position may include On-Call response for Facility
- Be exposed to outdoor weather conditions.
- Be exposed to noisy environments.
- Attendance is mandatory.FDBN works with technical data,
technology and materials that are subject to U.S. export laws and
regulations. This position will require access to technical data,
technology and source code that is controlled under U.S. export
laws and regulations, including but not limited to the
International Traffic in Arms Regulations at 22 C.F.R. Parts 120 -
130 and Export Administration Regulations in 15 C.F.R. Part 730 -
774, as may be amended. To conform to these laws and regulations,
applicants must be U.S. citizens, lawful permanent residents of the
U.S., protected individuals as defined by 8 USC 1324(b)(a)(3)
(i.e., asylees and refugees) or otherwise eligible for an export
authorization from the U.S. Department of State or U.S. Department
of Commerce. Offers of employment will be contingent on the
Company's ability to secure an export authorization.FDBN is an
Equal Opportunity Employer. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, national origin, disability, protected veteran
status, sexual orientation, gender identify or any other protected
class. If an accommodation to the application process is needed,
please email .To all agencies Please, no phone calls or emails to
any employee of FUJIFILM about this requisition. All resumes
submitted by search firms/employment agencies to any employee at
FUJIFILM via-email, the internet or in any form and/or method will
be deemed the sole property of FUJIFILM, unless such search
firms/employment agencies were engaged by FUJIFILM for this
requisition and a valid agreement with FUJIFILM is in place. 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
Keywords: FUJIFILM Diosynth Biotechnologies, Cary , DS Manufacturing Associate IV/V, Other , Holly Springs, North Carolina
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