Sr. Associate Digital Manufacturing

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

We are seeking a Sr. Associate Digital Manufacturing to lead various smart manufacturing technologies and computerized systems improvement initiatives within manufacturing. You will oversee critical processes, provide technical leadership, and be responsible for designing, implementation, and validation of systems and digital technologies.

Primary Responsibilities

• Provides technical support, project management, and troubleshooting assistance of various smart manufacturing technology and computerized systems within the manufacturing area (e.g. AR/VR Technology, MES, ERP, SCADA, Systech, Serialization).

• Support the site in the project approvals, prioritization, and manage the roll-out and implementation of smart manufacturing technology concept initiatives to support the manufacturing area.

• Support the business with the implementation of data analytics, reporting and provide insight in business critical KPIs and OEE (e.g. KPI tools, OEE, Spotfire).

• Support the manufacturing team during troubleshooting for key computerized systems and assist during problem solving.

• Act as manufacturing business representative in cross-functional meetings and support all levels of the organization to drive digital manufacturing projects.

• First line Subject Matter Expert (SME) for smart manufacturing technology, computerized systems, and MES and ERP.

• Assist in global harmonization strategic activities for digital manufacturing which include but not limited to design, improvements, system configuration, validation, and investigations.

• Support key business system lifecycle management activities and represent team during software or system upgrades.

• Generate, and review documents (SOPs, FORMs, Deviations, CAPA, CC, etc.) associated and owned by digital manufacturing team.

• Work with team to ensure training on new or revised digital manufacturing processes is effective and completed for end-users (Operators/Supervisors/Technical/QA/Support Staff).

• Uses the latest data analysis tools and methodologies to solve systematic problems and improve process efficiencies to maintain production schedule adherence.

• Work in teams as well as perform as an individual contributor to successfully achieve the predefined goals on time.

• Design and support lifecycle of manufacturing systems to support manufacturing operations.

Additional Responsibilities

• Act as liaison between IT department and manufacturing to support continuous operations.

• Support continuous improvements initiatives to unlock capacity on the manufacturing lines.

Qualifications

• Background in smart manufacturing technologies and key business systems (e.g. AR/VR Technology, MES, ERP, SCADA, Systech, Serialization).

• Build up knowledge on new processes, systems and technologies in an efficient way.

• Experience in either a GMP environment or ISO experience

Education & Certifications

• Master's Degree within Manufacturing, Engineering, or Computer Science experience OR Bachelor's Degree and 6 months of Manufacturing, Engineering or Computer Science experience OR Associate's Degree and 2 years of Manufacturing, Engineering or Computer Science experience OR High School/GED and 4 years of Manufacturing, Engineering or Computer Science experience.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.

• Operate other office productivity machinery, such as a calculator, scanner, or printer.

• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 35.00 - 45.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM's compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as candidate's qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.secure.force.com/Careers

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