POSITION OVERVIEW:

We are seeking a Sr. Validation Engineer with 7-11 years of experience to lead and 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 managing validation lifecycle documentation while ensuring compliance with regulatory expectations, data integrity requirements, and internal quality standards.

The Sr. Validation Engineer will serve as a subject matter expert for validation and computerized systems, providing QA/Validation oversight for Manufacturing Execution System (MES) and Electronic Batch Record (eBR) implementations, qualification activities, and system lifecycle management. This individual will partner closely with Manufacturing, Quality, Validation, Automation, and IT/OT teams to ensure successful system deployment, qualification, and ongoing compliance.

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, IQ, OQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, computerized systems, and other GMP-regulated assets.
• Provide QA/Validation oversight for MES and eBR implementation, qualification, and system lifecycle activities.
• Review and approve requirements, risk assessments, traceability matrices, validation plans, test protocols, deviations, change controls, and validation summary reports.
• Review eBR workflows and electronic manufacturing processes to ensure alignment with approved manufacturing procedures, master batch records, and GMP requirements.
• Ensure compliance with applicable regulatory requirements, including 21 CFR Part 11, GMP, data integrity, computerized systems validation (CSV), and industry best practices.
• Support deviation investigations, CAPAs, change controls, system releases, and go-live readiness activities for MES/eBR and other GMP computerized systems.
• Oversee validation activities for internal and client technology transfer projects, including authoring, executing, reviewing, and closing validation documentation.
• 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 validation, verification, commissioning, qualification, and requalification summary reports.
• Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, Manufacturing, 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 and computerized systems.
• Lead periodic reviews and requalification activities for validated equipment, systems, and temperature-controlled assets.
• Collaborate closely with Manufacturing, Validation, Automation, IT/OT, Quality, and project teams to ensure validation activities align with project timelines and operational requirements.
• Provide technical mentorship and guidance to junior validation staff and project team members.

QUALIFICATIONS AND REQUIREMENTS:

Education

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

Technical Experience

• 7-11 years of experience within the biotechnology, pharmaceutical, or medical device industry.
• Strong knowledge of FDA cGMP requirements, risk-based validation methodologies, and quality system requirements.
• Advanced validation expertise in equipment qualification, process validation, computerized systems validation (CSV), and automation systems.
• Demonstrated experience supporting MES and eBR validation, implementation, qualification, or lifecycle management activities within GMP manufacturing environments.
• Experience reviewing and approving validation documentation, including protocols, reports, requirements specifications, risk assessments, traceability matrices, and deviations.
• Extensive experience generating and executing IQ, OQ, PQ, CSV, and system qualification documentation.
• Experience supporting audits, regulatory inspections, remediation activities, and quality system compliance initiatives.
• Experience with MES platforms such as PAS-X, PharmaSuite, Syncade, Opcenter, or similar systems is strongly preferred.

Knowledge, Skills, and Abilities

• Strong understanding of GMP manufacturing operations, 21 CFR Part 11 requirements, data integrity principles, and computerized systems validation methodologies.
• Demonstrated MES/eBR validation and qualification experience within regulated pharmaceutical or biotechnology environments.
• Excellent technical writing, documentation review, and validation reporting skills.
• Strong verbal and written communication skills, with the ability to effectively collaborate across Manufacturing, Quality, Validation, Automation, Engineering, and IT/OT organizations.
• Highly organized with strong analytical, problem-solving, and investigation skills.
• Ability to lead validation workstreams, manage multiple priorities, and work independently in a fast-paced environment.
• Experience supporting deviation investigations, root cause analysis, CAPAs, and change management activities.
• Ability to mentor junior engineers and contribute to team development and knowledge sharing.

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.