默克生命科学
Validation Specialist
Validation Specialist
发布于 大约 2 个月前普通员工/个人贡献者
Burlington, Massachusetts, United States
初级经验
全职员工
仅现场办公
大专
质量管理
SOP
GMP
GLP
Validation
Labvantage
Bacterial Retention
AI 估算 · 32k–51k
Based on the provided hourly range ($28-$44) and typical full-time hours, the monthly salary is estimated between $4,480 and $7,
职位详情
关于这个职位
As a Validation Specialist at MilliporeSigma, you will perform bacterial retention validation tests for microbial filters, ensuring data integrity and compliance with SOPs. You will work in a sterile environment, coordinate with project managers, and contribute to robust documentation. This role is ideal for those with a life science background and experience in microbiology or validation.
最低要求
Associate Degree in a life science discipline (Microbiology, Chemistry, etc.)
+ years' experience in a bacterial retention validation or microbiology retention role
工作职责
Execute microbial filter validation tests
Plan testing runs
Maintain compliant documentation
Apply aseptic techniques in a sterile environment
Read and follow SOPs
Coordinate with Lab Manager and Project Manager
Ensure data integrity through accurate record-keeping and timely communication
优先资格
Bachelor's Degree in a life science discipline (Microbiology, Chemistry, etc.)
Proficiency in Good Documentation Practices and ALCOA+ principles
Experience with validation activities such as cleanroom aseptic technique, filter validation, and test plan development
Experience using laboratory software and tools (Excel, Word, LabVantage, Smartsheet)
Strong collaboration across cross-functional teams including Quality Assurance, microbiology, and manufacturing
Detail-oriented with solid data analysis and troubleshooting skills
Knowledge of GLP/GMP practices and ISO 9001:2015 standards
Commitment to continuous improvement and maintaining a safe, organized work environment
AI 洞察
优缺点分析
优点
- Work for a global leader in life sciences (MilliporeSigma) with extensive resources and stability.
- Develop specialized expertise in bacterial retention validation, a niche but critical skill.
- Gain hands-on experience with regulatory standards and data integrity practices.
- Work is primarily lab-based and may involve repetitive tasks under strict protocols.
- Requires meticulous attention to detail and adherence to rigorous documentation standards.
- Limited remote work flexibility
- role is fully on-site in Burlington, MA.
- Candidates with a life science degree and at least 1 year of lab experience who enjoy structured, compliance-driven work in a sterile environment.
缺点 / 挑战
暂无明显挑战项
角色解读
- Progress to Senior Validation Specialist or Team Lead within the validation team.
- Move into quality assurance or regulatory affairs roles with deeper compliance expertise.
- Advance to project management or laboratory management positions.
- Execute bacterial retention validation tests on microbial filters to ensure product safety and compliance.
- Plan testing runs and coordinate with project managers to meet timelines.
- Maintain thorough documentation following Good Documentation Practices and ALCOA+ principles.
- Proficiency in aseptic techniques and cleanroom operations for sterile environments.
- Experience with filter validation protocols and microbiological testing methods.
- Strong data integrity and documentation skills, including use of LabVantage and Smartsheet.
- Knowledge of GLP/GMP and ISO 9001 standards.
申请策略
- Tailor your resume to showcase attention to detail and data integrity examples.
- Research MilliporeSigma's product lines in bacterial filtration to demonstrate genuine interest.
- Emphasize any direct experience with bacterial retention or filter validation.
- Highlight proficiency in aseptic technique, cleanroom protocols, and GLP/GMP compliance.
- Include familiarity with ALCOA+ principles and Good Documentation Practices.
- If lacking direct validation experience, gain exposure through academic labs or internships.
- Familiarize yourself with LabVantage or similar laboratory information management systems.
面试指南
- Use the STAR method (Situation, Task, Action, Result) for behavioral questions.
- For technical questions, explain the process step-by-step, emphasizing compliance and quality.
- Describe your experience with aseptic technique and cleanroom protocols.
- How do you ensure data integrity in your documentation?
- Tell us about a time you troubleshooted a validation test failure.
- What is your understanding of ALCOA+ principles?
- How do you prioritize tasks when handling multiple testing runs?
- Review basic microbiology and filter validation concepts.
职位点评
64
综合评分
Stable role at a global life science leader with competitive pay, limited remote options, and solid compliance focus.
更适合这类人
Candidates prioritizing competitive compensation and job stability over remote flexibility.
表现最好
薪资福利
相对薄弱
工作生活
薪资福利80
成长发展65
工作生活40
使命价值70
薪资福利
80较高
The salary range is clearly provided and competitive for the role, with benefits including health insurance and PTO. The company is a large, established multinational offering stability.
薪资信号市场水准 (32K-50K/月)
福利待遇health insurance、paid time off、retirement contributions
成长发展
65中等
Opportunities for growth exist within the validation team, but the role focuses on execution rather than innovation. Company offers a culture of inclusion and development, but specific advancement paths are not detailed.
技术前沿传统/成熟技术
技术栈Bacterial Retention、Validation、Aseptic Technique、GLP、GMP
成长机会continuous improvement
业务类型ambiguous
工作生活
40较低
The role is fully on-site in Burlington, MA, with no mention of remote work or flexible hours. This may limit work-life balance for those preferring flexibility.
工作模式仅现场办公
办公地点科技园/产业园
加班情况未提及（无法判断）
使命价值
70中等
The role contributes to product safety in healthcare and life sciences, which has positive social impact. The company emphasizes innovation and enriching lives, but the role itself is more operational.
行业发展稳定成熟行业
社会影响正向社会影响力较高
使命信号enrich people's lives、drives excellence and innovation
创新程度稳健跟随主流
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