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Senior Validation Engineer
$93,000 - $125,000/Yr
Belmar Pharma Solutions - Lakewood & Golden, CO
posted 4 days ago
Full-time - Mid Level
Lakewood & Golden, CO
Health and Personal Care Retailers
About the position
The Sr. Validation engineer provides guidance and technical decision making to the Validation Engineer personnel regarding cGMP compliance, regulatory issues, validation strategy and quality systems for projects and/or strategic activities.
Responsibilities
- Provide support to site facilities, utilities, instruments and equipment qualification and process, packaging, computer systems, and cleaning validation.
- Prepare, review, and approve documentation for validation and qualification activities to support company, equipment, product and/or performance processes.
- Lead development of Master Validation Plans, Project Plans, and Test Plans.
- Provide guidance and oversee the maintenance of the validated state including requalification/revalidation of equipment and processes.
- Participate in job interviews, motivation, coaching, and training.
- Provides a professional, dynamic, cooperative, and high achieving work environment for the staff.
- Coaches the integration, verification and validation leads on technical, management and leadership.
Requirements
- Bachelor's degree in engineering (Chemical, Mechanical, Manufacturing, Electrical, or Software).
- Minimum 3 years of experience with pharmaceutical processes, systems, equipment, and applicable government regulations.
- Demonstrated success in leading large-scale, cross functional projects.
- Proven potential to effectively lead a team; obtaining results through people.
- Experience in technical writing.
- FDA Guidance for Industry, USP and cGMP experience.
- Mechanical aptitude required.
- Possess critical thinking skills to troubleshoot and commission equipment/processes.
- Proficient in Microsoft Office Applications.
- Excellent communication skills, both oral and written.
- Ability to work as part of a team and provide leadership.
- Ability to resolve conflicts and provide solutions.
- Must be able to read, understand and follow cGMPs, SOPs, Specs, and all guidelines as they relate to the process.
- Time management skills and the ability to manage oneself.
- Superior attention to detail.
Benefits
- Full-Time position
- Days shift
