Engineer II, Manufacturing
About The Position
In the position of Engineer II, Manufacturing, you will play a pivotal role within our dynamic manufacturing team, providing critical equipment support and engineering technical troubleshooting for drug substance manufacturing equipment. You will be an integral part of the team, managing small engineering projects with guidance, and participating in cross-functional teams to implement change and enhance existing processes. Your work will significantly contribute to new product Tech Transfer activities and investigations, ensuring our manufacturing processes are efficient and compliant. By supporting the design, specification, and installation of new equipment and modifications to existing systems, you will directly impact the quality and reliability of our manufacturing operations. Your contributions will be vital to maintaining our high standards and driving forward our innovation in drug manufacturing.
Requirements
- BS in Engineering.
- 0-2 years of experience in GMP validation, manufacturing, engineering, or facilities in a pharmaceutical environment.
- Knowledge of GMPs and EMEA regulations.
- Experience in Cleaning and Equipment Validation Philosophy.
- Experience in a pharmaceutical or biotech manufacturing environment.
- Excellent oral and written communication skills.
- Ability to work on-site.
- Ability to work rotating shifts/on-call, extended coverage support and weekends as needed.
Nice To Haves
- Demonstrated ability to identify efficiency gaps and implement best practices.
- Experience in supporting technology transfer and continuous improvement projects.
Responsibilities
- Troubleshoot and identify equipment system improvements to support manufacturing operations.
- Design and develop validation protocols and provide expertise for equipment and automation modifications.
- Coordinate equipment-related projects, including technology transfers and continuous improvement initiatives.
- Develop and manage Equipment & Cleaning Validation Protocols, offering technical training and on-floor guidance.
- Lead equipment commissioning and qualification activities, ensuring project deliverables are tracked and reported.
- Attend Factory Acceptance Testing (FAT) as a validation subject matter expert and support equipment startup.
- Maintain personal training records, goal development, compliance workflow, and progress tracking.
- Support the implementation of new manufacturing processes and technology transfers.
- Investigate process or equipment failures and implement corrective changes.
- Manage and track completion timelines for compliance tasks such as change controls and deviation investigations.
- Provide validation-related support for projects and continuous improvement initiatives.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Industry
Chemical Manufacturing
Number of Employees
5,001-10,000 employees
