Sr Engineer, Validation

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

About the role

The Sr. Engineer, Validation ensures cGMP regulatory compliance through adherence to site and corporate validation Plans, Policies, and Procedures. This position supports ensuring accountability and oversight within the validation program, validation projects, and leads innovation. The Sr. Engineer, Validation will independently work on multi-faceted projects (Capital, Client and Overhead), manage multiple tasks/priorities, and provide Subject Matter Expertise (SME) and oversight in multiple disciplines owned by the validation department, including:

• Commissioning and Qualification
• Computer Systems Validation
• Validation Maintenance/Risk Management
• Laboratory Systems Validation

The Sr. Engineer, Validation performs with a high degree of autonomy, represents the department on interdisciplinary teams, leads by example, achieves solutions to complex problems, serves as a technical expert, and provides leadership and technical guidance to the team.

Responsibilities

• Create and execute commissioning, qualification protocols, and validation protocols and plans (CX/IQ/OQ/PQ), including identification and resolution of non-conformances consistent with site procedures and practices.
• Provide equipment, system, and facility commissioning and qualification guidance and strategy execution during project planning and development phases.
• Review and approve technical documentation including system lifecycle design documentation (user requirements, functional and design specifications, commissioning and qualification protocols).
• Perform equipment, aseptic processing, steam sterilization, and process validation and their associated control systems.
• Review and approve department deliverables (protocols and quality systems).
• Perform investigations and implement corrective actions related to CAPAs and deviations.
• Develop broader skills personally and departmentally through resource and program development.
• Plan, coordinate, and execute assigned projects using Project Management methodologies.
• Participate in regulatory inspection and response activities.
• Represent validation on internal teams, committees, and at technical conferences.
• Report status and progress of qualification activities or projects to the Leadership team.
• Own assigned Validation Plans, Procedures, and Projects supporting program compliance.
• Manage and direct work for assigned projects ensuring activities are on time, within budget, meet GxP, and company requirements.
• Provide customer focus supporting engineering, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert within the Validation department.
• Propose unique solutions to complex problems using technical proficiency, creativity, and collaboration with others through independent thought, communication, and technical writing.
• Support and own process troubleshooting, operations support, root cause analysis, and risk assessment.
• Use proven monitoring and problem-solving techniques such as SPC and DMAIC.
• Exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Determine methods and procedures on complex assignments and implement them after obtaining necessary stakeholder approvals.
• Provide technical direction and guidance to engineers within the Validation department.

Requirements

• BS in Engineering, Chemistry, Microbiology, or related field and/or a minimum of 8 years of related industrial experience in system qualification or validation.
• Expert knowledge of validation principles and concepts.
• Demonstrated ability to use and operate independently within software common to Validation Departments: Microsoft (Word, Excel, PowerPoint), Kaye AVS.
• Strong knowledge of engineering and related practices, including governmental regulations – ISPE, EU, CFR 210, 211, Part 11.
• Experience with systems such as CIP, SIP, Autoclaves, Temperature Controlled Units, Critical Utilities, Facilities, Equipment systems, Computer or Controls Systems preferably used in a GMP environment.
• Ability to read and interpret drawings such as PFDs, P&IDs, and electrical schematics.
• Strong communication and computer skills.
• Demonstrated success in technical proficiency, creativity, collaboration with others, and independent thought.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities and business needs.

Pay

The estimated annual base salary as a new hire for this position ranges from $129,000 to $156,000. Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant’s geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.

Benefits

Emergent offers a comprehensive benefits package. Eligibility for benefits is governed by the applicable plan documents and policies. Information regarding additional benefits can be found here.