MES BA/Validation Lead at USDM Life Sciences

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

USDM is looking for a strong MES Validation Lead with BA experience.

Primary Responsibilities

• Develop validation documentation such as validation plans, functional design specifications, test protocols, and standard operation procedures for computerized systems used in GMP
  environment Analysis complex manufacturing business processes and identify, evaluate, develop and/or redesign systems, processes, and procedures to meet user requirements on
  large initiatives.
• Create detailed written user requirements.
• Responsible for planning, scheduling, and leading validation assignments. Must demonstrate competent and effective planning, coordination, and organizational skills.
• Participate and work closely with cross-functional team members (Engineering, Manufacturing, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements, as applicable, to develop the validation strategy and system validation requirements based on concepts of risk-based CQV which includes user requirements, functional specifications, design specifications, commissioning and validation. Emphasis is following regulatory guidelines and industry standards.
• Execute protocols, write reports, interpret, and evaluate validation documents in terms of acceptability to industry standards, procedures, and regulatory requirements. Review documentation for accuracy and compliance to established procedures with the ability to approve or reject as appropriate.
• Ability to present a course of action to management and project team using both written and verbal communication tools. Perform other duties as directed by supervisor.
• Persuade others with fact-based judgments of business situations.
• Understand business needs of stakeholders and identifies opportunities to enhance or resolve them through feedback loop with the business partner and the IT Lead.
• Develop and participate in the Criticality and Risk Assessment.
• Review and/or develop User Requirement Specification.
• Review and/or develop Functional Specification.
• Review and/or develop Design Specification(s).
• Develop Requirements Traceability Matrix.
• Commissioning and Qualification protocol(s) development, execution and failure logging and resolution.
• Develop Final Summary Reports.

Qualifications

• 7+ years of related Validation experience.
• Working knowledge of testing concepts, verification, and validation techniques, defect management, and risk management.
• Experience in manufacturing processes and control systems.
• Strong knowledge of GMPs, FDA and EU guidelines/requirements, is required. Must be considered a Subject Matter Expert (SME) in all validation elements.
• Experience in MES Implementation-Siemens Opcenter (plus).
• Demonstration of in-depth technical capabilities in system supported manufacturing in a regulated environment
• Ability to write and speak in the English Language.
• Excellent oral and written communications skills, business acumen with analytical, critical thinking and problem-solving skills.
• Strong communication and interpersonal skills.
• Technical attitude: ability to learn new systems and information quickly..
• Meticulous, conscientious, analytical, focused, self-starter.

Education & Certifications

• Bachelor's degree.

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.
• Travel to client site for onsite work as needed.

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 65.00 - 85.00

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.my.salesforce-sites.com/Careers