POSITION OVERVIEWWe are seeking a Sr. Validation Engineer with 7-11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP-regulated environments. This role is responsible for developing, executing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards. The Sr. Validation Engineer will serve as a subject matter expert, support complex technical projects, and provide guidance to junior team members.
KEY RESPONSIBILITIES(This list is not exhaustive and may be supplemented or adjusted as needed.)
- Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP-regulated assets.
- Oversee validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports.
- Write, review, and revise qualification and verification documents, including SOPs, validation master plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.
- Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities.
- Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
- Lead P&ID walkdowns to verify installation, configuration, and system readiness.
- Perform and oversee thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
- Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
- Lead periodic reviews and requalification activities for temperature-controlled systems and other validated assets.
- Provide technical mentorship and guidance to junior validation staff.
- Collaborate cross-functionally to ensure validation activities align with project timelines and operational needs.
QUALIFICATIONS AND REQUIREMENTSTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education
- Bachelor's degree in a life science, engineering, or related technical field.
Technical Experience
- 7-11 years of experience in the biotech, pharmaceutical, or medical device industry.
- Strong knowledge of FDA cGMP requirements, FMEA, and risk-based validation principles.
- Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and process validation.
- Extensive experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation.
- Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports.
- Experience supporting audits, regulatory inspections, and remediation activities.
Knowledge, Skills, and Abilities
- Strong verbal and written communication skills, with the ability to explain complex technical concepts to diverse audiences.
- Highly organized with strong documentation and analytical skills.
- Ability to lead validation workstreams, manage multiple priorities, and work independently.
- Strong problem-solving skills and experience supporting investigations and root-cause analysis.
- Ability to mentor junior engineers and contribute to team development.
ESSENTIAL FUNCTIONS:Physical Demands
: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.
Work Environment
: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.
TOTAL REWARDS PROGRAM:We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere." However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.
Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.
