Engineer I, Validation

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.