Validation Engineer/Specialist ( Mid to Senior Level)

  • Job Reference: 592960840-2
  • Date Posted: 15 May 2022
  • Recruiter: Mangan Inc
  • Location: Cary, North Carolina
  • Salary: On Application
  • Sector: Care in the community, Management & Supervisors, Restaurant & Service, Senior Care workers
  • Job Type: Permanent

Job Description

Validation Engineer/Specialist (Mid to Senior Level)
Location: Cary, NC

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. We are an employee owned company with opportunities for growth.

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:

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

Requirements:

5+ years' experience

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 with employer match
Company funded health and dental insurance with low employee cost sharing
Wellness & Vision subsidy
Company paid short term and long term disability coverage