SRG, the leader in the Life Sciences human capital industry, is looking for an Engineering Administrative Assistant to join our clients Biotech manufacturing team in Brooklyn Park, MN. This person will be responsible for supporting data entry and administration of engineering change proposals in the Quality Management System software, Trackwise.

*W2 contract only, we cannot accept C2C at this time

Must Haves:

• High School Diploma or equivalent required
• Experience in Pharmaceutical, Biotech, or Manufacturing environment is preferred
• Experience with Deviations, CAPAs, Change Control is preferred (Quality Management System software like Trackwise or AssurX/Catsweb
• Strong Knowledge of PC-based office tools such as Excel, Word, and Power Point
• Excellent oral/written communication skills

Roles and Responsibilities:

• Assist with single-use material qualification including documentation and date entry to ensure all proposed changes are accurately captured and reviewed for material Qualification needs
• Support data entry and document revisions (including equipment and material specifications and data forms) as generated by the execution of process engineering projects
• Collaborate cross-functionally to compile material qualification data and revise material specifications in the Veeva document management system (DMS).
• Collaborate with stakeholders to identify specific requirements for forms related to instrument calibration, material numbering, new spare parts, or equipment bill of material.
• Process and route forms ensuring timely reviews and approvals by relevant stakeholders and ensure they meet the requirements of local procedures and compliance requirements.
• Enter proposed to change control plans into the Trackwise software and act as administrator to track and document execution of the project deliverables.
• Support tracking and trending process equipment work orders.
• Interpret vender spare parts lists and draft proposed preventative maintenance plans with guidance from area-owner engineers.
• Compile data for process equipment maintenance assessments or periodic review reports.
• Draft equipment bill of materials lists to link spare parts with associated equipment.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.