Sr Engineer, Validation

Emergent Biosolutions; United States; On-site; USD 129,000 - 156,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Emergent BioSolutions seeks an experienced Sr. Engineer, Validation in the United States to ensure cGMP compliance across commissioning, qualification and validation activities.

You will provide SME oversight, lead multi-disciplinary projects, and drive best practices within the department. The role requires deep knowledge of validation principles, regulatory standards (ISPE, CFR), and the ability to guide teams, manage budgets, and coordinate with manufacturing sciences and quality.

Qualifications

• BS Engineering/Chemistry/Microbiology or related field and/or 8 years related industrial experience.
• Expert knowledge of validation principles and concepts.
• Proficient with Microsoft Word, Excel, and PowerPoint; Kaye AVS.
• Knowledge of ISPE, EU CFR 210, 211, Part 11 regulations.
• Experience with GMP-related systems (CIP, SIP, Autoclaves, etc.).

Responsibilities

• Owns and manages validation plans, procedures and projects.
• Performs and directs commissioning, qualification and validation activities.
• Reviews technical documentation and ensures compliance with regulatory standards.
• Leads investigations and CAPA/deviation resolutions.
• Represents the validation function on cross-functional teams.

Skills

Microsoft Word

Microsoft Excel

PowerPoint

Technical writing

Project management

Education

BS Engineering/Chemistry/Microbiology or related field

Tools

Kaye AVS

Job description

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.

Job Summary

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. Sr Engineer, Validation will independently work on multi-faceted projects (Capital, Client and Overhead), manage multiple tasks/priorities. Core competencies for this position are Collaborates, Communicates Effectively, Directs Work, Ensures Accountability and Customer Focus. This position provides Subject Matter Expertise (SME) and oversight in multiple disciplines owned by the validation department. These disciplines are; Commissioning and Qualification, Computer Systems Validation, Validation Maintenance/Risk Management, and Laboratory Systems Validation. The Sr. Engineer, Validation performs with a high degree of autonomy and represents the department on interdisciplinary teams. This position leads by example, achieves solutions to complex problems, serves as a technical expert, communicates effectively, collaborates and bridges GAPs. The Sr. Engineer, Validation supports engineering, quality, manufacturing sciences and technology, and manufacturing by providing SME support and accountability within the Validation department. The Sr. Engineer, Validation will also be responsible for providing leadership and technical guidance to the team aimed at implementing best practices and improving the overall performance of the team.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Technical Expertise

• Create and execute commissioning, qualification protocols, and validation protocols and plans (CX/IQ/OQ/PQ), including identificationand 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.


• Reviews 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.


• Developing broader skills personally by applying this knowledge to work assignments and departmentally through resource and program development.


• Plan, Coordinate, and Execute assigned projects by effectively using Project Management methodologies.


• Participate in regulatory inspection and response activities.


• Represents validation on internal teams, committees and at technical conferences.


• Report status and progress of qualification activities or projects to the Leadership team.

Leadership Skills

• Owns assigned Validation Plans, Procedures and Projects supporting program compliance.


• Manage and directs work for assigned projects ensuring activities are on time, within budget, meet GxP and company requirements.


• Possesses strong knowledge of current validation best practices, including governmental regulations and GxPs.


• Demonstrated success in technical proficiency, creativity and collaboration with others through independent thought, communication and technical writing.


• Provide customer focus supporting engineering, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert within the Validation department.

Problem Solving

• Proposes unique solutions to complex problems using technical proficiency, creativity and collaboration with others through independent thought, communication and technical writing.


• Supports and owns process troubleshooting, operations support, root cause analysis, and risk assessment.


• Uses proven monitoring and problem-solving techniques such as SPC and DMAIC.


• Exercising 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.


• Determining methods and procedures on complex assignments and providing technical direction and guidance to engineers within the Validation department.


• Demonstrate strong leadership and management qualities when working within the department and other stakeholder groups that yield results.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Experience & Skills

Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.

• BS Engineering/Chemistry/Microbiology or related field and/or a Minimum 8 years 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, Power Point), Kaye AVS.


• Possesses 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.


• Read and interpret drawings such as PFDs, P&IDs and electrical schematics. Strong communication and computer skills.


• Demonstrates success in technical proficiency, creativity, and collaboration with others and independent thought.


• Makes decisions exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Ensure alignment and communication of issues and strategies.


• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities and business needs.

U.S. Base Pay Ranges and Benefits Information

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.].

Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.