CQV/CSV Junior Engineer – Ref # BCJE001 Full Time

The Career Foundation is currently seeking a full-time CQV/CSV Junior Engineer on behalf of one of our employer partners.

• Salary: Negotiable
• Benefits: Upon successful completion of probation, you will also be enrolled in our benefit programs:

1. Life Insurance
2. Accidental Death
3. Long Term Disability
4. Dental and Healthcare

Responsibilities:

Technical Writing and Field Execution (CQV, CSV, Quality Compliance) 

• Work with various stakeholders to draft, route for review, update, and route for approval technical documents. Some examples of such documents are:
• Requirement documents (for example, URS, FS, HDS, SDS) associated with process equipment and process utilities such as PW, WFI, Clean Steam, Compressed air, etc
• SOP’s, Work Instructions, equipment operation & maintenance instructions, technical reports, technical summaries to support regulatory submissions.
• Validation master plans, test protocols (for example, FAT, SAT, IQ, OQ, PQ, UAT) and reports.
• Data Analysis, Trend Analysis.
• Conduct field execution at various client sites (travel is required based on individual client requirements).

Project Co-ordination (CQV, CSV, Quality Compliance) 

• Develop, maintain and track project planning deliverables i.e. project charter, project plans, budgets, project schedules, risk register, and communication plan.
• Monitor costs and resources availability, develop forecasts and initiate actions to address resource constraints or cost overruns.
• Prepare and facilitate project meetings, review deliverables and action items, assign project tasks to team members and conduct follow-ups on actions.
• Monitor and manage project change request, identify impact of change on project schedule, costs, risk and share with stakeholders.
• Provide status updates in form of presentations, reports, dashboards to various stakeholders on a regular basis, including issue escalation as required.
• Coordinate activities with team members, contractors, software developers, system integrator, network support, maintenance, and operations to ensure all project activities are completed as per schedule.
• Support the tracking defects, deviations identified during execution of test. Work with appropriate stakeholders to resolve defects in a timely fashion.
• Support any other tasks as assigned to you to meet project requirements.

Requirements:

• Previous experience in engineering, quality assurance and compliance in the pharmaceutical or biopharmaceutical industry is a must.
• Excellent verbal and written communication skills.
• Strong interpersonal and organization skills.

This employer partner is an equal-opportunity employer. We thank all candidates for their interest; however, only those selected will be contacted for an interview.