Engineer II

Bend, Oregon /
Operations – Engineering /
Full-time Exempt
The role of the Engineer II within the Operations Department works collaboratively with a cross-functional team to develop practical and thorough solutions to engineering needs, and lead and execute validation activities including equipment commissioning and qualifications. Engineer II interfaces with internal stakeholders from Manufacturing, Product and Process Development, Quality Control and Quality Assurance, in addition to external vendors. 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. Successful candidates will have a passion for engineering and a capacity to learn all aspects of the machine/project lifecycle from a multi-disciplined team.

Duties and Responsibilities

    • Implement and coordinate commissioning and qualification of manufacturing equipment and facility systems for use in regulated and non-regulated operations
    • Perform qualification and validation of manufacturing equipment and facility systems, including FAT, SAT, Design Qualification, Installation and Operations qualifications, and Performance qualifications
    • Support installation activities to ensure proper systems startup and recommend changes to improve system design
    • Regularly interact and foster relationships with external development partners and equipment suppliers
    • Create and implement standard operating procedures (SOP)ensuring alignment with current Serán best practices
    • Prepare P&ID drawings, markups, and technical specifications
    • Ensure compliance with current pharmaceutical standards such as ASME BPE, GAMP, cGMP, ISPE guidelines
    • Execute Change Controls, Deviations, and Investigations resulting from equipment and facility qualification and annual requalification protocol execution
    • Mange, schedule, implement, and track multiple projects and activities of moderate complexity with multi-functional departments to ensure accurate completion
    • Provide training in area of expertise within equipment and process validation
    • Work in accordance with Serán's quality management system
    • Assist in completing equipment maintenance and maintain critical instruments in a calibrate state
    • Other related duties as assigned

Required Skills and Abilities

    • knowledge of CQV requirements and procedures for manufacturing equipment and facility support systems
    • Excellent oral and written communication skills
    • Ability to work within a collaborative team
    • Highly organized and detail oriented
    • Excellent time management skills with a proven ability to meet deadlines
    • Ability to prioritize tasks and delegate when appropriate
    • Proficient with Microsoft Office Suite
    • Proficient with DraftSight CAD software, or equivalent

Education and Experience

    • Bachelor's degree in Engineering, Life Sciences, or related discipline
    • Minimum three years of relevant experience in manufacturing environment, preference given to those with pharmaceutical manufacturing experience
    • Must have experience with cGMP and Good Engineering Practices
    • Track record of managing multiple projects at once while leading cross-functional teams
    • Experience with EHS, ISO, cGMP, and other regulatory requirements in manufacturing environment

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