Engineer I, Validation

Serán BioScience; Bend (OR); In loco; USD 70.000 - 95.000; Tempo pieno

Vantaggi offerti da questo lavoro

Paid time off (four weeks)

Retirement contributions after 90 days

Various health plans

Basic life and long-term disability

Employee Assistance Program with pet保险

Descrizione del lavoro

Serán BioScience in Bend, Oregon seeks an Engineer Associate or Engineer I to support validation activities for pharmaceutical manufacturing equipment and processes. The role covers design, operation, and decommissioning of qualification activities for tablets, capsules, and spray drying dispersion used in clinical trials.

You will collaborate with Facilities Engineering to prepare URS, IQ/OQ/PQ, Change Control, CAPAs, and ensure GMP-regulated documentation.

Competenze

• Authors qualification and validation protocols and reports.
• Demonstrates mechanical aptitude with a problem-solving mindset.
• Strong analytical skills to interpret technical data and equipment performance trends.
• Excellent written communication for compliant documentation.
• Ability to collaborate with cross-functional teams in client-driven environments.

Mansioni

• Collaborate with Facilities Engineering and Maintenance during installation, calibration, and routine maintenance.
• Develop and manage system lifecycle documentation (URS, SFD, IQ/OQ/PQ, Traceability Matrix, Cx reports, Change Control, Risk Assessments).
• Support equipment readiness for tech transfers, ensuring qualification aligns with URS and regulatory expectations.
• Perform equipment testing, data collection, and analysis to verify performance against specifications.
• Maintain validation documentation (protocols, reports, traceability metrics, lifecycle).
• Assist with SOPs and related documents; troubleshoot issues with cross-functional teams.
• Ensure GMP compliance and timely release for GMP use following qualification and cleaning activities.
• Perform investigations, CAPAs, change requests, and engineering projects.
• Scope may increase with company initiatives; perform other related duties.

Conoscenze

Qualification protocols & reports

Mechanical aptitude

Data analysis

Regulatory documentation

Cross-functional collaboration

Written communication

MS Suite proficiency

QMS learning ability

Formazione

BS Degree in Engineering

1 year GMP experience (Engineer I)

0 GMP experience (Associate Engineer)

Strumenti

Microsoft Office

Descrizione del lavoro

Serán is seeking an Engineer Associate or Engineer I to support validation activities associated with pharmaceutical manufacturing equipment, utilities, computerized systems, facilities, and processes. This position is a crucial role in maintaining, scheduling, and executing qualification and validation activities for the manufacturing of tablets, capsules and spray drying dispersion for the use of clinical FDA trials. The successful candidate will support all facets of the validation life cycle including design, operation, continuous improvement, and decommissioning of manufacturing equipment. Preference will be given to candidates with pharmaceutical industry experience within a GMP environment to best inform decisions and provide direction for the assurance of product quality.

While industry experience is preferred, those with minimum education and experience are encouraged to apply. Serán seeks applicants who demonstrate an aptitude to apply their engineering education and background to a new industry and gaining experience in cGMP regulatory environment. Job title and salary commensurate on experience within pharmaceutical industry.

Duties & Responsibilities

• Collaborate with Facilities Engineering and Maintenance during equipment installation, calibration, and routine maintenance
• Assist with the develop and learn to manage system lifecycle documentation consisting of User Requirements (URS), Functional and Design Specifications, Testing Protocols (Cx/IQ/OQ/PQ), Traceability Matrix, Qualification Summary Reports, Change Control, and Risk Assessments
• Support equipment reediness for tech transfers, ensuring qualification aligns with client URS, process needs, and regulatory expectations
• Perform equipment testing, data collection, and analysis to confirm performance against specifications and process requirements
• Maintain complaint validation documentation, including protocols, reports, traceability metrics, and equipment lifecycle
• Assist with the generation and maintenance of SOPs and supporting documents
• Work with cross-functional teams to troubleshoot equipment, process, and validation issues
• Perform job responsibilities in compliance with applicable GMP regulations and guidelines as applied to the fields of Systems Qualification, Cleaning, and Process Validation
• Ensure equipment is released for GMP use within agreed-upon timelines following qualification and cleaning activities
• Perform investigations, CAPAs, change requests, and engineering project
• Scope of work may increase to align with company initiatives
• Perform other related duties as assigned

Required Skills and Abilities

• Authors qualification and validation protocols and reports
• Demonstrates mechanical aptitude with a proven ability to problem-solve
• Strong analytical skills with the ability to interpret technical data and equipment performance trends
• Excellent written communication skills for generating clear, compliant documentation
• Ability to work collaboratively with cross-functional teams in a client-driven environment
• Strong verbal and written communication skills
• Excellent organizational skills with attention to detail and commitment to documentation accuracy
• Ability to prioritize work independently and ask for assistance when appropriate
• Ability to focus in a fast-paced environment with shifting priorities
• Proficient with Microsoft Suite or related software, with the ability to learn new QMS systems

Education & Experience

• BS Degree in Engineering discipline
• Engineer I qualifications amount to a minimum of 1 year of previous GMP experience with background in the Pharmaceutical, Biotech, Chemical, Validation, or QA industry
• Associate Engineer qualifications require 0 GMP experience with the minimum education requirements

Physical Requirements

• Adheres to consistent and predictable in-person attendance
• Ability to work in cleanroom or controlled manufacturing environments as needed
• Occasional lifting of equipment components (up to ~25 lbs).
• Ability to stand for extended periods during equipment qualification or testing.

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary:

• Serán employees accrue over four weeks of paid time off annually.
• Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period.
• Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions.
• Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage.
• An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701