Job Store Professional has partnered with a global Pharmaceutical Manufacturing Company to fill their new Senior Validation Engineer position in Englewood, CO. This could be the change you've been looking for if you're seeking your next direct hire position with a company that is constantly evolving, putting their most important consumer first- the patients. 

Company Overview: 

Our vision is to make the world a healthier place to live, and that starts with you! We believe everyone can be an impact player. Join our team and discover a career, not just a job. Our culture is centered around talent development where employees are given opportunities of growth to make a difference in our company as well as the world.

Position Overview:

The Validation Engineer reports directly to the Senior Manager of Technical Services. The role is responsible for as a SME for the Commissioning, Qualification, and Validation (CQV) processes for the site. This includes commissioning and qualification of the equipment, process validation, facilities qualification, utilities qualification, and Continued Process Verification. This role may be a specialist in other topics such as Computer Software Validation or Analytical Instrument Qualification. This role ensures all systems operate within regulations to ensure the production of quality products for the Company’s 503B cGMP manufacturing facility.

Salary Range: $115K-140K Annually plus benefits.

Essential Duties & Responsibilities: 

Works on projects/matters in primarily an ownership capacity. Communication may be directed towards the project team and direct management, or the audience may be a wider cross-functional group, including the Executive Leadership Team as appropriate.

Utilizes Project Management skills to plan, lead, and coordinate efforts with a cross-functional team.

Adheres to GDP/GMP guidelines to author, review, or support technical documents including but not limited to change controls, CQV protocols and reports, and CAPAs.

Coordination of Validation activities with stakeholders.

Writes and executes protocols for Validation work including highly complex systems.

Identifies and resolves non-conformances/deviations encountered during IQ/OQ/PQ execution and work with cross function team to implement mitigation solutions.

Generates CQV reports and summarizes results, including confirming the document is suitable to be shared with clients or regulatory agencies.

Performs and documents Validation Gap Assessments and Risk Assessments for simple or moderately complex systems, including addressing gaps and mitigating risks.

Supports creation or revision of Validation templates for protocols and reports.

Supports and reviews Engineering Documentation (URS, FS, SAT, FAT).

Supports project work as a specialist on complex technical and business matters.

Acts as a Subject Matter Expert for some or all of the following topics: 

Equipment CQV (Commissioning, Installation Qualification, Operational Qualification) 

Process Validation (Performance Qualification, Process Performance Qualification) 

Continued Process Verification (Monitoring and Analyzing processes through Statistical Process Control, Gap Assessments, Risk Assessments, Requalification, Change Control Assessments) 

Aseptic Practices (Smoke Studies, Media Fills / Process Simulations, Sterilization, Filtration of air or product, Microbiology including Endotoxin, Environmental Monitoring, and Bioburden)

EXPERIENCE AND NECESSARY SKILLS:

Bachelors degree in the sciences required; i.e. chemical engineering, chemistry, or relevant industry experience.

Relevant experience and skillset 7+ years for Senior.

Experience considered when determining level: 

Experience in a highly regulated environment (preferred pharmaceutical, will consider biotechnology or related fields) including a significant exposure to regulatory requirements. 

Aseptic Processing

 Experience in project management Knowledge of cGMP requirements as they pertain to the validation of manufacturing and lab equipment in a pharmaceutical environment. 

Validation experience.

Statistical Analysis using software (JMP, MiniTab, Saas, etc.)