Validation Systems Engineer

2 weeks ago

Fort Worth, Texas, United States PSC Biotech Full time
Job Overview
PSC Biotech is dedicated to providing vital services to the life sciences sector, ensuring that healthcare products are developed, manufactured, and distributed in accordance with the highest standards and all relevant regulatory requirements.

Our mission is to elevate our clients' success, and you can contribute to our collective achievements. With a diverse team of skilled professionals across strategically located offices in North America, Europe, Asia, and the Middle East, we take pride in the roles we play in our clients' successes.

Professional Environment

At PSC Biotech, we are passionate about uniting the best talents from around the globe to create something exceptional. By joining our organization, you will have the opportunity to feel inspired in your career, pursue your professional interests, and collaborate with a team that values and nurtures your skills.

We are committed to mentoring and developing the next generation of industry leaders. Therefore, you will receive a competitive compensation and benefits package, along with the resources necessary for your growth and learning.

At PSC Biotech, we believe that your career is more than just a job—it's about your future.

Your Responsibilities

We are seeking a CSV Engineer to assist with MES for Electronic Batch Records. Key responsibilities include:
  • Contributing to the development of MES system lifecycle strategies and business/technical processes for change management.
  • Configuring, programming, troubleshooting, and testing MES systems.
  • Completing project deliverables accurately and efficiently, including URS, FRS, OQ, PQ, VMP, TM, ECOs, etc.
  • Executing CSV protocols.
  • Generating and executing validation documents (System Testing, IQ, OQ, PQ, UAT).
  • Creating Software Configuration Documentation, including validation plans, test cases, and validation summaries.
  • Providing support across various CSV tasks.
  • Assisting in the planning, development, and implementation of computer systems validation documentation.
  • Initiating and overseeing system CSV-related change control requests and associated validation documentation.
  • Authoring, reviewing, and approving scheduled periodic reviews.
  • Participating in computer validation project activities and creating planning documents and testing protocols.
  • Reviewing test results and identifying areas for improvement.
  • Reviewing and modifying Standard Operating Procedures (SOPs).
  • Analyzing validation data and compiling reports as necessary.
  • Collaborating with project stakeholders and the information systems team to define needs and feasible solutions to system requirements.
  • Completing additional tasks as assigned.


Qualifications
  • 3-5 years of experience in Computer Systems Engineering.
  • Technical background in IT/Engineering.
  • Experience in the Pharmaceutical industry, preferably in eye care.
  • Experience in a cGMP manufacturing environment.
  • Proficiency with Siemens MES.
  • Ability to read and interpret dimensional specifications and drawings.
  • Strong knowledge of CSV deliverables such as URS, FRS, OQ, PQ, VMP, TM, ECOs, etc.
  • Demonstrated initiative for learning.
  • Excellent interpersonal and communication skills.
  • Ability to work collaboratively with internal and external suppliers.
  • Willingness to travel for project assignments and client engagements, adapting to different locations and cultures as necessary.


Benefits
PSC Biotech offers a comprehensive benefits package, focusing on investing in our employees who contribute to our mission and success. We promote a healthy work-life balance, ensuring you have the time and resources to lead a fulfilling life.
  • Medical, Dental, and Vision coverage, with PSC covering 100% of 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) plan with matching contributions.
  • PTO, Sick Time, and Paid Holidays.
  • Education Assistance programs.
  • Pet Insurance options.
  • Fitness Benefits, including membership discounts at qualifying gyms.
  • Financial perks and discounts.

Equal Opportunity Employment Statement:
PSC is committed to a policy of Equal Employment Opportunity for all employees, interns, and applicants. We adhere to all applicable federal, state, and local laws regarding employment discrimination, prohibiting discrimination against qualified individuals in all aspects of employment.

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