Validation Associate, Facilities and Operations

Serán BioScience; Bend (OR); Vor Ort; USD 55.000 - 75.000; Vollzeit

Benefits dieser Stelle

Paid time off

Retirement account

Health plans

Life insurance

Long-term disability

Employee Assistance Program

Pet insurance

Zusammenfassung

Serán BioScience in Bend, Oregon is seeking a Validation Associate to support qualification and validation activities for pharmaceutical manufacturing equipment, processes, and computerized systems used in tablet and capsule production for clinical FDA trials.

You will document lifecycle activities, work with cross-functional teams to troubleshoot equipment and validation issues, ensure GMP compliance, and help release equipment on schedule.

Qualifikationen

• Broad knowledge of Pharmaceutical GMP, FDA and international regulations.
• Strong documentation practices and change control understanding.
• Excellent verbal and written communication skills.
• Excellent organizational and time management skills.
• Proven problem-solving and analytical abilities.

Aufgaben

• Develop and manage system lifecycle documentation (URS, FDS, IQ/OQ/PQ, Traceability Matrix, Qualification Summary Reports).
• Assist with generation and maintenance of SOPs and supporting documents.
• Collaborate with cross-functional teams to troubleshoot equipment, process, and validation issues.
• Ensure GMP-compliant validation activities and timely release of equipment after qualification and cleaning.
• Perform investigations, CAPAs, change requests, and engineering projects.

Kenntnisse

GMP knowledge

Documentation

Communication

Time management

Problem solving

Teamwork

Office software

Ausbildung

Bachelor’s degree

Tools

Microsoft Office

Jobbeschreibung

The Validation Associate is responsible for supporting validation activities associated with pharmaceutical manufacturing equipment, utilities, computerized systems, facilities, and processes. This position 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. 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.

Duties & Responsibilities

• Develop and 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.
• 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 projects.

Required Skills & Abilities

• Must have a broad knowledge of Pharmaceutical GMP, along with FDA and international regulations.
• General understanding of change control, CAPA programs, investigation and root cause analysis, and good documentation practices.
• Excellent verbal and written communication skills.
• Excellent interpersonal and collaborative teamwork skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Proven project management skills while working independently.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to function well in a high‑paced and at times stressful environment.
• Proficient with Microsoft Office Suite or related software.

Education & Experience

• Minimum of a bachelor’s degree, preferably in a scientific discipline. Equivalent experience may be considered in lieu of degree.
• 0-2 years previous GMP experience with background in the Pharmaceutical, Biotech, Chemical, Validation, or QA industry.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift 15 pounds at times.
• Adheres to consistent and predictable in-person attendance

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