Our company’s Solutions organization develops applications for regulated industries based on our process control system SIMATIC PCS 7 and PCS neo, in addition to our Manufacturing Execution System, Opcenter Execution Pharma. Projects implemented on our systems in pharmaceutical and other GxP regulated industries require formal Commissioning, Qualification, Validation (CQV) prior to implementation to production. This position will support the project implementation teams.
We are seeking an entry level resource to grow our Validation / Quality group responsible for contributing to Commissioning, Qualification, and Validation (CQV) activities for pharma projects and quality oversight for projects in general under the guidance of the Validation/Quality Lead and/or project CSV Lead. This resource will be a part of the project teams supporting the above-mentioned activities.
You must have a keen focus on quality and attention to detail, with excellent verbal and written communication skills.
Your responsibilities may include the following:
- Quality review of system documentation and assist with project document management tasks.
- Assist with development of CQV lifecycle documentation (Validation Plan / Master Test Plan / Risk Analysis / Project Standard Operating Procedures (SOPs) / Trace Matrices, etc.).
- Assist with development of test documents (FAT/SAT test specifications / test plans / test summary reports).
- Assist with system test execution for FAT/SAT.
- Assist with development and execution of test documents for IQ/OQ/PQ on projects.
- Contribute to internal quality by assisting with drafting internal procedures, creation of internal and project documentation templates, continuous improvements of internal processes and procedures.
The position is based out of Harleysville, PA reporting directly to the hiring manager
Required Knowledge/Skills, Education, and Experience
- BA/BS in Engineering or Science discipline.
- Entry level, yet willing to consider 1 plus years of experience.
- Strong collaboration skills and positive attitude towards teamwork.
- Ability to effectively interact/communicate with client resources.
- Ability to work independently with a sense of urgency to meet deadlines.
- Problem solver that displays an effective approach to decision-making, flexible to handle changing priorities.
- Ability to quickly learn multidisciplinary skills and concepts.
- Ability to multi-task.
- Ability to manage and direct tasks in areas of quality oversight.
- Ability to pay strong attention to details.
- Willing to assist in other areas that need assistance to meet deadlines and help with other value-added issues requiring resolution.
- Flexibility and willingness to travel and work at various client sites.
- Strong technical writing and communication skills.
- Proficient with Microsoft Office – Word, Excel, PowerPoint, Visio.
Preferred Knowledge/Skills, Education and Experience
- BA/BS preferably in Biochem/Chemical Engineering, Computer Science/Information Technology, or Electrical Engineering.
- Familiar with CSV concepts.
- Familiar with Automation and/or Manufacturing Execution Systems.
- Familiar with cGMP, GDP, 21CFR Part 11 and other relevant FDA guidelines.
Organization: Digital Industries
Company: Siemens Industry, Inc.
Experience Level: Early Professional
Full / Part time: 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.
Siemens is a technology company centered on the industries that form the backbone of economies – manufacturing, infrastructure, and transport. Our... Read more