POSITION OVERVIEWWe are seeking a Validation Engineer with 4-7 years of experience to support commissioning, qualification, validation (CQV), and computer system validation (CSV) activities across equipment, utilities, facilities, laboratory systems, manufacturing processes, and computerized systems. This role will be responsible for developing, executing, reviewing, and maintaining validation lifecycle documentation, with a strong emphasis on qualification records managed within the Kneat validation platform.
The Validation Engineer will collaborate with cross-functional teams to ensure validation activities are completed in compliance with GMP regulations, data integrity requirements, internal quality standards, and project timelines. This position plays a critical role in supporting operational readiness, technology transfer, change management, and continuous improvement initiatives.
KEY RESPONSIBILITIES(This list is not exhaustive and may be supplemented or adjusted as needed.)
- Develop, review, execute, and maintain commissioning, qualification, and validation protocols and reports within the Kneat validation system.
- Generate and execute validation lifecycle documentation, including FAT, SAT, IQ, OQ, PQ, and CSV deliverables for equipment, utilities, facilities, laboratory systems, manufacturing processes, and other GMP-regulated assets.
- Author, execute, review, and close validation documents including validation plans, risk assessments, protocols, reports, discrepancy investigations, and summary reports.
- Support qualification and validation activities for analytical laboratory equipment, manufacturing systems, and computerized systems in accordance with applicable regulatory requirements.
- Support technology transfer projects through validation planning, protocol execution, documentation review, and qualification activities.
- Develop and revise validation documentation, including SOPs, Master Validation Plans, execution plans, URS, FRS, design specifications, commissioning protocols, verification protocols, and test procedures.
- Collaborate with Engineering, Manufacturing, Quality Assurance, Quality Control, and project teams to ensure successful execution of validation activities.
- Support change controls, impact assessments, deviation investigations, CAPAs, and validation assessments for GMP systems and processes.
- Perform P&ID walkdowns and system inspections to verify installation and operational readiness.
- Conduct thermal mapping studies and support qualification activities for controlled environments and temperature-controlled systems.
- Support regulatory inspections, audits, and remediation activities related to validation and qualification programs.
- Perform periodic reviews, requalification activities, and lifecycle management of validated systems and equipment.
- Ensure all validation documentation complies with current GMP requirements, data integrity expectations, Good Documentation Practices (GDP), and company procedures.
- Independently manage assigned validation projects while effectively communicating status, risks, resource needs, and project milestones.
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
- 4-7 years of experience in the biotech, pharmaceutical, or medical device industry.
- Strong knowledge of FDA cGMP requirements, FMEA, and risk-based validation principles.
- Hands-on validation experience in equipment, computerized systems (CSV), analytical methods, and process validation.
- Experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation.
- Demonstrated experience writing IQ, OQ, PQ, and CSV reports.
Knowledge, Skills, and Abilities
- Strong verbal and written communication skills, with the ability to explain technical concepts to non-technical stakeholders.
- Detail-oriented with strong organizational and documentation skills.
- Ability to work independently and collaboratively in a fast-paced, regulated environment.
- Strong problem-solving skills and the ability to support investigations and root-cause analysis.
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.
