DS Manufacturing Associate IV/V

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 Responsibilities

Project Phase

• 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 templates.
• 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 operational topics.
• 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 instructions.
• 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 (Minimum)

• Basic math add, subtract, multiply, divide, fractions, percent etc.
• Basic conversational and written English. 
• Must have excellent work ethics, personal responsibility, initiative and teamwork.
• Must have excellent hand-eye coordination, manual dexterity and physical durability.
• 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 little rework.
• 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 years

Mental & 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 punctual.
• 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 complete problems.
• 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 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 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 issues.
• 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 lena.lee@fujifilm.com.

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 paid.