Validation Engineer/Specialist ( Mid to Senior Level) at Mangan Inc

Cary, NC 27511

About the Job

Validation Engineer/Specialist ( Mid to Senior Level)

Mangan Biopharm is a subsidiary division of Mangan Inc. and is a full service Engineering and Life Science Quality and Compliance Company. Mangan has over 25 years of experience in Engineering, Procurement and Construction with 15+ years of experience in Lifesciences Engineering and Compliance Consulting. We are customer-centric and fully committed to our clients needs and as a result, most of our business is repeat business.

Position Summary:

The Validation Engineer/Specialist is responsible for execution of validation projects for equipment, facilities, and utilities in a pharmaceutical manufacturing, packaging, or support environment. The candidate must be able to work independently, but be able to coordinate execution efforts with operations, manufacturing, facilities, laboratories, development, materials management and quality assurance personnel. This role will play an integral part in overall project success.

Duties:

Validation Engineer/Specialist ( Mid to Senior Level)
Experience: 5+ years
- Analyze validation data, prepare summary reports and provide recommendations for
 improvement in manufacturing process and equipment
- Develop training packages, JSAs and writing Best Known Methods (BKM) for Validation
- Serve as a dependable liaison between validation and manufacturing
- Identify, respond to and monitor potential project risk and determine possible contingency plans
 for risk mitigation
- Reviews technical and quality system documents such as SOPs, Change Control and Deviation
 - Reports, Batch Production Records, Technical Manuals, P&IDs, construction, as-built, flow diagrams 
as they relate to validation principles and regulatory compliance issues
 
 Education: BS in technical field is a plus 

Other Skills/Qualifications: 
- Good understanding of cGMP validation requirements / guidelines and current industry practice 
- Results-oriented, able to make decisions, and able to prioritize validation project and client needs 
- Excellent organization and time management skills 
 Strong teamwork and collaboration 
- Must have excellent interpersonal, technical writing and communication skills 
- Proficient in use of MS Office software suite 

Benefits:
- Competitive salary with a discretionary bonus potential 
- Benefit Time Off (BTO) that can be used as paid vacation, sick time, holiday funding, or as cash-out 
- Employee Stock Ownership Plan (ESOP) & 401(k) plan for retirement
- Company funded health insurance 
- Wellness & Vision subsidy 

Salary

85,000.00 - 110,000.00 /year
+ Discretionary Bonus