默克生命科学
Senior Project Engineer
Senior Project Engineer
发布于 大约 2 个月前普通员工/个人贡献者
Jaffrey, New Hampshire, United States
高级经验
全职员工
仅现场办公
本科
项目与项目集管理
FMEA
GMP
FAT/SAT
Bio-Pharmaceutical
AI 估算 · 70k–105k
Senior level in biotech, multinational company, competitive base salary reflected in provided range.
职位详情
关于这个职位
As a Senior Project Engineer at MilliporeSigma, you will lead large-scale investment projects in the Life Science business unit, managing technical scope, equipment validation, and project governance. You will work on multi-million dollar projects, ensuring compliance with GMP and quality regulations, while collaborating with cross-functional teams across North America. This role is ideal for experienced engineers with a background in biotech or pharmaceutical manufacturing seeking to drive impactful technical solutions.
最低要求
BS or MS in Engineering (Mechanical Engineering preferred); 5 years of professional experience in medical, biotechnology, or Bio-pharmaceutical manufacturing environment is highly preferred.
工作职责
Manage Equipment validation and qualification
Manage change control and re-validation to maintain ongoing compliance.
Equipment build, commissioning, and start-up
Influence equipment design inputs, vendor selection, and build for manufacturability and reliability.
Lead FAT/SAT, installation/commissioning, site acceptance testing, and handover to operations.
Develop and maintain WBS, schedules, milestones, and critical-path analyses.
Establish vendor evaluation criteria, due diligence, and gating processes.
Conduct hazard analyses, FMEA; ensure alignment with internal standards and regulatory requirements.
Create and Maintain standardized templates for charters, business cases, and risk registers
Provide clear, factual reporting to stakeholders and governance bodies.
优先资格
PMP certification preferred, not required. Fluent in English with excellent communication skills and profound knowledge of quality regulations. Ability to analyze situations and develop optimized solutions. History of successfully implemented equipment or systems. Prior experience in medical, biotechnology or similar field. Knowledge of manufacturing concepts and GMP. Strong communicator, self-starter, ability to prioritize and work on multiple projects. Enthusiastic, cooperative, and positive behavior. Significant skills and experience in project management and history of successfully executed smaller technical investment projects ($0.5M-$10M) as a project lead. Ability to work effectively and have demonstrated documentation skills. Inclusive and can identify required resources.
AI 洞察
优缺点分析
优点
- Work on high-budget, strategically important projects with cutting-edge life science technologies.
- Join a global top-tier company with strong brand and resources for professional development.
- Competitive compensation and comprehensive benefits including health insurance, PTO, and retirement contributions.
- Up to 30% domestic travel may impact work-life balance.
- High responsibility for compliance and project deadlines in a regulated environment.
- Requires deep technical and regulatory expertise
- learning curve for those new to pharma GMP.
- Experienced engineers with a background in biotech/pharma manufacturing who thrive in a project-driven, regulated environment and seek impactful industrial projects.
缺点 / 挑战
暂无明显挑战项
角色解读
- Progress to Senior Project Manager or Program Manager leading larger portfolios.
- Move into Engineering Management or Site Leadership roles within the organization.
- Specialize in process engineering or validation to become a subject matter expert.
- Lead the technical scope and execution of large-scale capital projects in life sciences manufacturing.
- Manage equipment validation, qualification, and change control to maintain regulatory compliance.
- Coordinate with internal teams and vendors to ensure equipment design meets GMP and operational needs.
- Conduct risk assessments (FMEA) and drive continuous improvement in project governance.
- Deep knowledge of GMP, equipment validation, and quality regulations in biotech/pharma.
- Strong project management skills including WBS, schedule, and vendor evaluation.
- Hands-on experience with FAT/SAT, commissioning, and startup of manufacturing equipment.
- Excellent communication and cross-functional collaboration, self-starter with minimal supervision.
申请策略
- Tailor your resume to demonstrate expertise in the specific validation processes (IQ/OQ/PQ).
- Research MilliporeSigma's Life Science portfolio and mention how your experience aligns with their product lines.
- Highlight specific projects where you led equipment validation and commissioning in a GMP setting.
- Quantify project budgets (e.g., $5M+ projects) and your role in delivering on time and within budget.
- Showcase PMP certification or equivalent project management methodologies.
- Emphasize cross-functional collaboration with vendors, quality, and operations teams.
- Familiarize with FDA/EMA regulations for medical devices and pharmaceuticals.
- Strengthen risk analysis skills (FMEA, HAZOP) and project scheduling tools (MS Project, Primavera).
面试指南
- Use STAR (Situation, Task, Action, Result) to structure answers with concrete examples.
- Focus on demonstrating regulatory knowledge and systematic problem-solving.
- Emphasize collaboration with cross-functional teams and stakeholder communication.
- Describe a time you managed a complex equipment validation project. What were the key challenges and outcomes?
- How do you ensure compliance with GMP while meeting aggressive project timelines?
- Walk me through your approach to conducting a FMEA for a new manufacturing system.
- Tell me about a project where you had to influence vendor selection for optimal manufacturability.
- How do you handle change control and re-validation after equipment modifications?
职位点评
69
综合评分
High-paying senior project engineer role in biotech manufacturing, strong benefits and purpose, but requires on-site presence and travel.
更适合这类人
This role is best suited for candidates who prioritize high compensation and meaningful work in life sciences, and are willing to accept on-site work and travel.
表现最好
薪资福利
相对薄弱
工作生活
薪资福利85
成长发展60
工作生活50
使命价值80
薪资福利
85较高
Salary range is clearly disclosed and above market average for the role. Benefits include health insurance, PTO, and retirement contributions, providing strong financial security.
薪资信号偏高 (70K-105K/月)
福利待遇health insurance、paid time off (PTO)、retirement contributions
成长发展
60中等
The role offers exposure to large-scale projects and state-of-the-art solutions, but lacks explicit mention of training programs or career progression paths.
技术前沿传统/成熟技术
技术栈GMP、Equipment Validation、FAT/SAT、FMEA、Process Engineering
业务类型ambiguous
工作生活
50较低
Position requires on-site work at a manufacturing facility in a small town, with up to 30% domestic travel. Work-life balance signals are absent from the JD.
工作模式仅现场办公
办公地点工厂/生产基地
加班情况未提及（无法判断）
使命价值
80较高
The company emphasizes enriching lives through healthcare and life science, and the role directly contributes to manufacturing solutions that improve patient outcomes.
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、Spark Discovery and Elevating Humanity
创新程度积极采用新技术
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