POSITION OVERVIEW:

We are seeking a Validation Engineer with 4-7 years of experience to support validation activities across equipment, utilities, facilities, computerized systems, manufacturing processes, and MES/eBR platforms within GMP-regulated environments. This role is responsible for developing, executing, reviewing, and maintaining validation lifecycle documentation while ensuring compliance with regulatory requirements, data integrity standards, and internal quality procedures.

The Validation Engineer will support MES and eBR implementation and qualification activities, working closely with cross-functional teams including Manufacturing, Validation, Automation, IT/OT, and Quality. The successful candidate will contribute to validation strategy, execution, documentation review, and system release activities while ensuring alignment with GMP and computerized systems validation requirements.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or adjusted as needed.)

• Generate and execute validation lifecycle documentation, including FAT, SAT, IQ, OQ, PQ, and validation reports for equipment, utilities, facilities, computerized systems, and other GMP-regulated assets.
• Provide validation support and oversight for MES and eBR implementation, qualification, and lifecycle management activities.
• Review requirements, risk assessments, traceability matrices, test protocols, deviations, and validation reports to ensure compliance with approved validation methodologies.
• Review eBR workflows to verify alignment with approved manufacturing processes, master batch records, and regulatory requirements.
• Support compliance with 21 CFR Part 11, GMP, data integrity, and computerized systems validation (CSV) requirements.
• Assist with deviation investigations, CAPAs, change controls, system releases, and go-live readiness activities.
• Author, execute, review, and maintain validation documentation including validation plans, protocols, reports, SOPs, URS, FRS, and design specifications.
• Support technology transfer projects by executing and documenting validation activities in accordance with project timelines and quality requirements.
• Prepare validation summary reports and support qualification and requalification activities.
• Participate in commissioning and qualification activities, including system walkdowns and verification exercises.
• Support thermal mapping and validation activities for temperature-controlled environments and systems, as applicable.
• Assist in the resolution of audit observations, regulatory findings, and manufacturing issues related to validation and computerized systems.
• Collaborate with Manufacturing, Quality, Engineering, Automation, and IT/OT teams to support successful project execution and operational readiness.
• Maintain validation documentation in accordance with quality system requirements and document control procedures.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field.

Technical Experience

• 4-7 years of validation experience within the pharmaceutical, biotechnology, medical device, or other regulated life sciences industry.
• Experience supporting equipment qualification, computerized systems validation (CSV), process validation, or automation system validation activities.
• Experience authoring and executing validation documentation, including IQ, OQ, PQ protocols and validation reports.
• Familiarity with risk-based validation methodologies and regulatory expectations within GMP environments.
• Experience supporting validation activities for MES, eBR, or manufacturing automation systems is preferred.
• Experience with MES platforms such as PAS-X, PharmaSuite, Syncade, Opcenter, or similar manufacturing systems is preferred.
• Experience supporting audits, inspections, deviation investigations, CAPAs, and change controls is preferred.

Knowledge, Skills, and Abilities

• Understanding of GMP manufacturing operations, 21 CFR Part 11, data integrity principles, and computerized systems validation requirements.
• Demonstrated experience supporting MES/eBR validation or computerized system qualification activities in a regulated environment.
• Strong technical writing and documentation skills with attention to detail.
• Ability to review and interpret validation documentation, process flows, requirements specifications, and test scripts.
• Strong organizational, analytical, and problem-solving abilities.
• Effective verbal and written communication skills with the ability to collaborate across multiple functional areas.
• Ability to manage multiple assignments and priorities in a fast-paced project environment.
• Working knowledge of validation lifecycle deliverables and quality system processes.
• Ability to work independently while contributing effectively within cross-functional teams.

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.