Manufacturing Engineer I
Bend, Oregon /
Operations – Manufacturing /
Full-time Non-exempt
/ On-site
Interested in starting or growing your engineering career in the field of pharmaceutical development and manufacturing? The Manufacturing Operations team is looking for engineers to help ensure equipment is maintained to meet regulatory standards for novel drug products. Manufacturing Engineers work collaboratively with a cross-functional team (manufacturing, product development, quality, and vendors) to develop practical and thorough solutions to engineering needs. The Manufacturing Engineer will lead and execute validation activities including equipment commissioning and qualification. The primary focus of this role is to be the technical leader to take the specified manufacturing and facility systems from procurement, installation, testing, to ultimate GMP manufacturing readiness.
Duties and Responsibilities
- Implement and coordinate commissioning and qualification of manufacturing equipment and facility systems for use in regulated and non-regulated operations
- Author commissioning and qualification of CSV documents through system life cycle, including deliverables such as user requirements, functional/design specifications, qualification protocols, reporting, and support documentation
- Support installation activities when needed to ensure proper systems startup and recommend changes to improve system design
- Regularly interact with external development partners and equipment suppliers
- Create and implement standard operating procedures ensuring alignment with current Serán best practices
- Prepare drawings, mark ups and technical specifications
- Ensure compliance with current pharmaceutical standards such as ASME BPE, GAMP, cGMP, ISPE guidelines
- Develop and manage schedules for small engineering project scopes
- Work in accordance with our established quality management system
- Assist in completing equipment maintenance and maintaining critical instruments in a calibrated state
- Other duties as assigned
Required Skills and Abilities
- Knowledge of CSV requirements and procedures for manufacturing equipment and facility support systems
- Excellent oral and written communication skills
- Ability to work in a team, highly organized, and detail oriented
- Excellent time management skills with a proven ability to meet deadlines
- Ability to prioritize tasks and to delegate them when appropriate
- Proficient with Microsoft Office Suite or related software
Education and Experience
- B.S, M.S, or an advanced degree in Engineering
- No GMP experience required
Physical Requirements
- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift up to 15 pounds at times
- Prolonged periods of time standing, kneeling or climbing ladders
- This position has a variety of shift options
