Validation Engineer

Validation Engineer – Various
Location: Southern California/Inland Empire

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.

We are seeking a variety of Validation Engineers. Individual details are below:

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Validation Engineer (Equipment & Cleaning)

Position Summary:

The Validation Engineer is responsible for validation services supporting qualification activities associated with autoclaves, lyophilizers, Isolators, process tanks, fillers and related process equipment for Aseptic Filling, including documentation generation and revision.

Duties:

• Generation of protocols, summary reports and protocol exceptions
• Scheduling and execution of qualification activities
• Qualification data collection and analysis against acceptance criteria
• Documentation updates (SOPs, Forms, etc.)
• Meeting attendance and project coordination

Requirements:

4-8 + years’ equipment and cleaning validation experience in Biopharma industry experience

Education:

BS in Engineering or Life Sciences

Preferred Experience:

• Good understanding of Fillers, Autoclaves, Isolators, Process Tanks, Lyo, CIP, SIP, IQ, OQ, PQ

Validation Engineer (Process, Equipment & Cleaning)

Position Summary:

The Validation Engineer is responsible for execution of validation services for drafting an executing protocols and final reports and their associated tasks including qualification activities related to formulation equipment and processes.

Duties:

• Generation of protocols, summary reports and protocol exceptions
• Scheduling and execution of qualification activities
• Qualification data collection and analysis against acceptance criteria
• Documentation updates (SOPs, Forms, etc.)
• Meeting attendance and project coordination

Requirements:

4-8 + years’ equipment and cleaning validation experience in Biopharma industry experience

Education:

BS in Engineering or Life Sciences

Preferred Experience:

• Good understanding of Process Validation, SIP, Utilities IOPQ, CIP, Parts Washer

Validation Engineer (Utilities, Equipment & Cleaning)

Position Summary:

The Validation Engineer is responsible for validation services for drafting risk assessments and executing protocols and final reports and their associated tasks, including qualification activities related to formulation equipment and processes.

Duties:

• Generation of protocols, summary reports and protocol exceptions
• Scheduling and execution of qualification activities
• Qualification data collection and analysis against acceptance criteria
• Documentation updates (SOPs, Forms, etc.)
• Meeting attendance and project coordination

Requirements:

4-8 + years’ equipment and cleaning validation experience in Biopharma industry experience

Education:

BS in Engineering or Life Sciences

Preferred Experience:

• Good understanding of Process Validation, SIP, Utilities (WFI, Pure Steam, N2, CDA) IOPQ, Parts Washer

Validation Engineer (Automated Systems, Equipment & Cleaning)

Position Summary:

The Validation Engineer is responsible for validation services supporting qualification activities associated with process equipment and associated document generation and revision.

Duties:

• Generation of protocols, summary reports and protocol exceptions
• Scheduling and execution of qualification activities
• Qualification data collection and analysis against acceptance criteria
• Documentation updates (SOPs, Forms, etc.)
• Meeting attendance and project coordination

Requirements:

4-8 + years’ Automated Systems Validation (CSV) validation experience in Biopharma industry experience

Education:

BS in Engineering or Life Sciences

Preferred Experience:

• Good understanding of Automated systems qualifications, Equipment qualification, SIP, cleaning validation

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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