Engineer Senior Top 3 Must Have Skill Sets: - Background in Single Use Technologies
- Background in Process Engineering
- Project management skills
- Validation experience
Red Flags: HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At our company, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
What you will do Let’s do this! Let’s change the world! In this vital role, you will be part of the Drug Substance Technology and Engineering group within the Process Development organization. One of the primary responsibilities will be providing technical leadership for Single Use components and assemblies. In this role, you will also introduce new technologies to the network and will be supporting investigations of our global manufacturing.
Responsibilities: - Support of Single Use network in terms of design and investigation
- Use process engineering and equipment design experience, to assess unit operation performance and work with both suppliers and the internal network to resolve equipment and single use consumable challenges.
- Analyze available data, research technical subjects, and work with other subject matter experts to support resolution of critical investigations.
- Provide leadership on capital projects.
- Provide process development representation on capital projects, ensuring process requirements are incorporated into equipment and facility designs.
- Support and/or lead design of flexible manufacturing equipment and single use consumables, including support of factory acceptance testing and onsite commissioning and qualification.
- Support the company's single use global network as a drug substance domain expert.
- Provide leadership on various work streams related to improving robustness of design, specification, and qualification of single use consumables and equipment.
- Lead technical assessments for supplier and internally inspired changes, evaluating impact to fit and function.
- May support technical visits to evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost, throughput, or other unique capabilities to our manufacturing.
This role will be mostly remote, with the occasional need to be on site. The person in this position is required to be located within 100 miles of Cambridge, MA or Thousand Oaks, CA.
What we expect of you We are all different, yet we all use our unique contributions to serve patients. The detail oriented professional we seek is a highly skilled problem solver with these qualifications.
Basic Qualifications: - High school diploma/GED and 12 years of Engineering or Operations experience
OR
- Associate’s degree and 10 years of Engineering or Operations experience
OR
- Bachelor’s degree and 5 years of Engineering or Operations experience
OR
- Master’s degree and 3 years of Engineering or Operations experience
OR
Preferred Qualifications: - Master’s degree and 6+ years of directly related experience, or PhD with 2+ years of directly related experience
- Strong understanding of GMP equipment design and biologics manufacturing requirements
- Detailed knowledge of multiple unit operations
- Experience leading root cause analyses and solving GMP manufacturing issues
- Ability to apply sophisticated problem solving skills within defined constraints
- Experience providing process engineering support of pilot/clinical/commercial processes
- Experience with large capital projects, including design, procurement, commissioning and qualification of production scale equipment
- Experience with single-use component design and application in biopharmaceutical production
- Experience developing and transferring process technology into GMP production environment
- Excellent technical writing and verbal communication skills
- Excellent facilitation and influencing skills
Some of the vast rewards of working here - As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Pay range is $34 - $39 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
