Siemens Opcenter Validation Engineer - United States - USDM

    USDM
    USDM United States

    1 week ago

    $900,000 - $1,200,000 (USD) per year
    Description
    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 set 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
    *** Hands on experience with Siemens Opcenter is required.
    We are seeking an experienced MES Validation Resource with experience in Siemens Opcenter to support validation activities within a regulated biotech/pharmaceutical manufacturing environment. The ideal candidate will have a strong background in Computerized System Validation (CSV), with a proven track record of testing MES applications in compliance with FDA 21 CFR Part 11, EU Annex 11, and other regulatory requirements.
    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.
    • Review and update user requirements and functional specifications.
    • 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.
    • Validate interface data transfer between integrated systems to ensure data integrity, traceability, and proper system data retrieval.
    • Maintain accurate validation records and documentation (including validation plans, functional specifications, protocols, and SOPs) to support compliance, audits, and inspections in GMP environments.
    • Maintain accurate and complete records of validation and testing activities to support audits and inspections.
    • Identify, log, and track software defects and discrepancies.
    • Collaborate with development and quality validation teams to troubleshoot and resolve issues.
    • Lead and coordinate validation assignments, demonstrating strong organizational and planning skills while shaping validation strategies based on risk-based CQV principles.
    • Continuously recommend and implement improvements to validation methods, tools, and
    • documentation standards to drive efficiency and maintain compliance.
    • 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.
    Additional Responsibilities
    • Performs other related duties and assignments as required
    Qualifications
    • Hands-on validation experince with Siemens Opcenter is required.
    • Must have experience in pharmaceutical/biotech validation which includes the writing and
    • executing of protocols and standard operating procedures.
    • Experience in manufacturing processes and control systems,
    • Strong knowledge of GMPs, FDA and EU guidelines/requirements, is required.
    • Proficient in writing test cases, test scripts, and validation documentation.
    • Experience with test management and defect tracking tools (e.g., Jira, TestRail, HP ALM).
    • Experience with Siemens Opcetner
    • Understanding of system development life cycle (SDLC) and Agile/Waterfall methodologies.
    • Exposure to enterprise systems such as ERP, LIMS, DeltaV, OSIPI or other business-critical
    • applications.
    Education & Certifications
    • Bachelor's degree in engineering discipline required. 7+ years of related 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
    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 the 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.
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