Senior Validation Engineer – Michigan
The Equipment Senior Validation Engineer authors, reviews and executes qualification and validation documents with processes and coordinates activities with cross-functional teams including performing FATs, validation assessments, quality deviations and change controls. The position requires experience with GDP, authoring documents, use of the Kaye Validator 2000, and knowledge of the corporation’s products and processes. The Senior Validation Engineer 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.
- Possesses strong knowledge of validation and related practices, including governmental regulations. Developing broader skills and applies this knowledge and skills to perform a variety of standard activities.
- Demonstrated success in technical proficiency, creativity, and collaboration with others and independent thought
- Develops/execute and review validation test plans & protocols consistent with site procedures and practices
- Reviews and approve validation related system lifecycle design documentation (user requirements, functional and design specifications, commissioning and qualification protocols)
- Perform equipment, aseptic processing, steam sterilization, cleaning validation and process validation and their associated control systems
- Manages validation activities within timeline commitments including developing a plan with timeline, deliverables, and accountabilities
- Represents validation on projects and in addressing issues. Develop and recommend solutions outside general practices with a focus on continuous improvement and compliance.
- Develop systems that promote and result in improved efficiency within the department and company.
- Summarize major project validation activities in reports.
- Represents validation on internal teams, committees and at technical conferences
- Provide an engineering-based validation review and input for CAPAs and Deviations.
- Solves a range of varied and complex problems requiring analysis/interpretation and are solved using knowledge/skills, precedents and practices. These include but not limited to process troubleshooting, operations support, root cause analysis, and risk assessment to document and accept risk.
- Exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
- Determine methods and procedures on new moderately complex assignments and implement them after obtaining necessary stakeholder approvals.
- Determining methods and procedures on new complex assignments, and providing technical direction to other engineers within the Validation department
- Demonstrate strong leadership and management qualities when working within the department and other stakeholder groups that yield results.
- BS Engineering/Chemistry/Microbiology or related field
- Minimum 8 years related industrial experience in the area of process or cleaning validation
- Expert knowledge of validation principles and concepts
- Basic skills and fluency in Microsoft Word and Excel
- Possesses strong knowledge of engineering and related practices, including governmental regulations – ISPE, EU, CFR 210, 211, Part 11, BPE.
- Reputation as emerging leader in field with sustained performance and accomplishment
- Experience with systems such as Controlled Temperature units, Critical Utilities, Facilities, Equipment systems, Computer or Controls Systems preferably used in a GLP or GMP environment
- Strong communication and computer skills
- Demonstrates success in technical proficiency, creativity, and collaboration with others and independent thought.
This global biopharmaceutical company is a proven leader in Innovative Advanced Development & Manufacturing and is set for continuous growth. They have been providing and improving prevention vaccines, medical countermeasures, and therapeutics to treat a multitude of disorders and illnesses for decades. Worth over $450 Million, and currently producing more than 20 commercial products, they are expanding. The culture is one of shared goals for product development, manufacturing, and encouraging employee health & wellness. They offer comprehensive benefit packages and reward results and performance. The culture embraces flexibility, work-life balance, empowers their employees, and strives to create a professionally, and personally rewarding environment. This facility is in an idyllic setting and is recognized as one of the Best and Most Beautiful Cities to Live in America! Apply today!