The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Company:

Bionova Scientific LLC

Job Description:

Company Summary:

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.

Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.

Position Summary:

We are seeking a skilled IT Engineer to join our dynamic team at Bionova, a rapidly growing Biologics CDMO. The ideal candidate will provide front desk support, ensure data integrity, and develop comprehensive policies, procedures, and SOPs for the IT department. This role requires a blend of technical expertise, regulatory knowledge, and strong communication skills to support the facility's IT infrastructure while maintaining compliance with GMP standards.

Essential Duties and Responsibilities:

• Provide technical assistance to users for hardware, software, and network issues.
• Manage the IT helpdesk, responding to service requests and troubleshooting issues promptly.
• Set up and configure new employee workstations and manage user access permissions.
• Deactivate accounts and retrieve IT assets from departing employees.
• Coordinate IT-related requests from visitors and vendors, ensuring compliance with visitor policies.
• Ensure the accuracy, consistency, and reliability of data across all IT systems.
• Implement and monitor backup procedures to protect data integrity.
• Develop and maintain disaster recovery plans to ensure business continuity.
• Develop comprehensive IT policies that align with company objectives and regulatory requirements.

• Define detailed procedures for IT operations to ensure consistency and efficiency.

• Document processes for incident management, change control, and system maintenance.
• Ensure all data handling practices comply with GMP regulations and other relevant standards.
• Develop SOPs for all IT-related tasks to ensure compliance with GMP standards.
• Regularly review and update SOPs to reflect changes in technology and regulations.
• Train IT staff and other employees on new and updated SOPs and monitor adherence.
• Utilize programming skills, preferably in Python, and scripting knowledge (shell scripts, PowerShell, etc.) to automate tasks and improve efficiency.
• Manage and maintain cloud infrastructure by utilizing experience with AWS, Azure, or Google Cloud.
• Implement and maintain robust cybersecurity measures, including penetration testing and vulnerability assessments.
• Administer and maintain Microsoft SQL Server, SQLite, and PostgreSQL databases.
• Be comfortable working in a clean manufacturing environment, requiring gowning up.

• This role may occasionally require to be available for on-call support during weekends to address critical IT issues.
• Work closely with the quality team to manage IT-related CAPAs, SOPs, policies, work instructions, and deviations.

Working Conditions:

• This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching.  The employee must occasionally lift and or move up to 20 pounds independently.
• This is a full-time, on-site position, working standard business hours Monday through Friday.
• We have multiple work sites within a mile of each other. Reliable transportation (personal vehicle) is required to move between locations as needed.
• Our facility includes GMP (Good Manufacturing Practice) zones. You will frequently work in these areas, which require proper gowning or double gowning attire to maintain safety and quality standards.

Qualifications:

• Education: Bachelor’s degree in computer science, Information Technology, or a related field.
• 5+ years of experience in an IT Engineer or similar role.
• Relevant IT, cloud certifications are a plus.
• Excellent communication and interpersonal skills, strong problem-solving abilities, and the ability to work both independently and collaboratively.
• Must have deep knowledge of Windows 10, 11, and Server environments, including Group Policy and Windows Administration.
• Must have experience managing Microsoft 365 environment.
• Must have GMP regulatory compliance experience in a manufacturing facility. 

Compensation Range: The base compensation range for this role is between $80,000 and $110,000. However, the actual compensation may vary depending on your experience and qualifications.

Health Benefits and Program: Bionova offers health benefits at a subsidized rate.

Healthcare, Dental, and Vision insurance

Life Insurance and Disability Program: 100% covered by Bionova.

Retirement Plan (401K) Up to 8% of Employer Match

Paid time off up to two weeks

10 days of Holidays and 5 days of Sick Leave.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.