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MES System Specialist

2 months ago

Fort Worth, Texas, United States PSC Biotech Full time
About PSC Biotech

PSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.

Job Summary

We are seeking a highly skilled CSV Engineer to support our Manufacturing Execution System (MES) for Electronic Batch Records. The successful candidate will play a critical role in the development of our MES system life cycle strategy and business/technical processes for change management.

Key Responsibilities
  • Participate in the development of MES system life cycle strategy and business/technical processes for change management.
  • MES system configuration, programming, troubleshooting, and testing.
  • Accurately and efficiently complete project deliverables: URS, FRS, OQ, PQ, VMP, TM, ECOs, etc.
  • Perform execution of CSV protocols.
  • Generate and execute validation documents (System Testing, IQ, OQ, PQ, UAT).
  • Write Software Configuration Documentation, including validation plan, test cases, and validation summary.
  • Provide a range of support in a variety of CSV tasks.
  • Participate/support the planning, development, and implementation of computer systems validation documentation.
  • Initiate and oversee system CSV associated change control requests and associated validation documentation.
  • Author, Review and or approve scheduled periodic reviews.
  • Participate in computer validation project activities and create computer system planning documents and testing protocols.
  • Review test results and identify areas of improvement to implement changes.
  • Review and modify Standard Operating Procedures (SOPs).
  • Review and analyze validation data -compiling reports when required.
  • Collaborate with project stakeholders and the information systems team to define needs and achievable solutions and/or justifications to system requirements.
  • Additional requirements as assigned.
Requirements
  • 3-5 years of Computer Systems Engineering experience.
  • Technical background in IT/Engineering.
  • Experience working in the Pharmaceutical industry, preferably within eye care.
  • Experience in cGMP manufacturing environment.
  • Must have experience working with Siemens MES.
  • Ability to read and interpret dimensional specifications and drawings.
  • Experienced with strong knowledge in CSV deliverable such as URS, FRS, OQ, PQ, VMP, TM, ECOs, etc.
  • Strong learning initiative.
  • Strong interpersonal skills and excellent communication skills.
  • Team player with the ability to work with internal and external suppliers.
  • At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements.
Benefits

PSC Biotech offers a comprehensive benefits package, including:

  • Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents.
  • Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
  • 401(k) and 401(k) matching.
  • PTO, Sick Time, and Paid Holidays.
  • Education Assistance.
  • Pet Insurance.
  • Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).
  • Financial Perks and Discounts.
Equal Opportunity Employment Statement

PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.