Back

Sr. Validation Engineer - Life Sciences -Buffalo Grove, IL or Major City US

Job Description


Validation Engineer for Life Sciences

Who designs your future? You do.

Are you looking for a career where you can showcase your technical aptitude and passion for problem solving to ensure your customers can work in a comfortable, safe, and energy-efficient environment? Then look to Siemens!

Join our team! Recognized by Fortune as World’s Most Admired Companies 2020

Our Culture:
At Siemens, we live and foster an ownership culture, in which every employee takes personal responsibility for our company's success. We trust and empower our leaders to act as owners, direct their teams, and innovate to succeed. We communicate openly and honestly to learn from our failures and celebrate our successes. We recognize individual and team achievements frequently. We invest in our team members, offering a wide variety of internal and external development opportunities.

About this role:

The Validation Engineer is responsible for the execution and management of validation projects within North American.

*Candidate can live anywhere in the US as long as they are near a major airport.

Responsibilities:

  • Development of support systems to improve operational effectiveness of branch operations on cGMP/cGLP regulated projects
  • Assist field offices on issues related to cGMP/cGLP regulated customers.
  • Develop, maintain and rollout documents and systems used in Bio-Pharmaceutical cGMP/cGLP regulated projects. Documents include standard validation protocol templates, standard operating procedure (SOPs) templates, and functional / design specification templates.
  • Defines, designs, plans, schedules, and assists in execution of field office validation work, including but not limited to factory and site acceptance tests, and validation protocols.
  • Authors and secures customer approval on all validation-related documentation, to include functional specification, design specification, project implementation plan, test procedures (FAT, SAT), validation protocols, standard operating procedures, summary reports, etc.
  • Assists with the execution of validation work by field office personnel and ensures that they are properly trained and qualified.
  • Facilitates interaction and communication with field operations to maintain a common reference and provide assistance with Biopharmaceutical related issues.
  • Periodically assist Field Operations with Lab/Critical Environments project tasks (design/hardware selection, terminal sizing, start-up/troubleshooting, training etc.) & provide support for Life Science Department initiatives.

Required Knowledge/Skills, Education, and Experience:

  • Working knowledge of FDA cGMP validation requirements specific to facility utility systems and software control systems.
  • Sufficient formal education and/or experience in a related field to gain an understanding of: Pharmaceutical processes and plant design, cGMP principles, documentation practices and validation requirements including but not limited to software, hardware and electronic records
  • Working knowledge of relevant technologies (e.g. HVAC, Clean Room, IT networks, etc).
  • 3+ years of experience in writing and executing formal test plans and standard operating procedures.
  • Excellent verbal and written communication skills, computer skills, financial skills and effective project management skills. Must be proficient in Microsoft Word.
  • Ability to travel up to 30%.
#LI-TMHSI

Organization: Smart Infrastructure

Company: Siemens Industry, Inc.

Experience Level: Mid-level Professional

Job Type: Full-time



Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here.

Can't find what you are looking for?

Let's stay connected

Can't find what you are looking for?