Validation Engineer

POSITION OVERVIEW:

We are seeking a Validation Engineer to join our team. The ideal candidate will leverage expertise in validation processes, quality systems, and regulatory compliance to ensure that all equipment, systems, and processes meet the required standards. This position requires a strong understanding of validation principles, technical excellence, and the ability to work cross-functionally to support critical business initiatives.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented and changed as necessary.)

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, and processes.
• Maintain and enhance validation quality systems to ensure compliance with regulatory requirements (e.g., FDA, EMA).
• Develop and improve standard operating procedures (SOPs), work instructions, and quality documentation related to validation processes.
• Lead and implement change management strategies to support product lifecycle changes and minimize operational impact.
• Plan, execute, and oversee validation projects from concept through implementation, ensuring alignment with product launch timelines and regulatory requirements.
• Develop project scopes, timelines, and resource plans to ensure seamless coordination with cross-functional teams.
• Identify project risks and implement risk mitigation strategies including process improvements and regulatory compliance.
• Analyze existing validation workflows, identify opportunities for process improvements, and implement best practices to increase efficiency and reduce risk.
• Drive continuous improvement initiatives to streamline validation processes, enhancing compliance, productivity, and cost-effectiveness.
• Provide technical expertise and troubleshooting support for validation-related issues, including root cause analysis and corrective action planning.
• Collaborate with regulatory, quality, and manufacturing teams to evaluate and execute changes, supporting a first-time-right approach.
• Ensure that all validation specifications meet regulatory and process standards.
• Serve as a key liaison between quality assurance, manufacturing, regulatory affairs, and supply chain to align validation strategies with overall business objectives.
• Support product launches, updates, and regulatory requirements by coordinating with cross-functional teams to achieve timely and compliant product releases.
• Facilitate team huddles and weekly planning meetings with cross-functional resources involved in the project, including teams both inside and outside of the CQV organization.
• Coordinate work related to the CQV process during the design phase of greenfield builds.
• Work closely with QA, QC, Automation, Engineering, Validation, CapEx, EH&S, Utilities startup group, and Upstream and Downstream Processing teams by running meetings and providing project oversight.
  • Follow up on action items and deliverables.
  • Communicate and address timelines and delays with internal stakeholders.
• Act as a support resource to the PM in handling coordination, tracking vendor status, tracking project status, validating user requirements, documentation, and meeting minutes.
• Drive coordination of daily, weekly, and monthly activities for assigned areas, focusing on execution, staffing coordination, and area availability.

QUALIFICATIONS AND REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Education:

• Bachelor’s degree in Engineering, regulatory affairs, or a related field.

Technical Experience:

• Minimum of 5-7 years of experience in validation engineering, with specific expertise in equipment, systems, and process validation.
• Deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to validation processes.
• Proficiency with quality systems including change control and quality events.
• Demonstrated success in managing multiple projects in parallel.

Knowledge, Skills, and Abilities:

• Excellent communication skills with the ability to work effectively across departments and influence stakeholders.
• Strong project management skills, with the ability to manage multiple projects simultaneously.
• Strong leadership and team management abilities.
• Detail-oriented with strong analytical and problem-solving capabilities.
• Ability to work in a fast-paced, dynamic environment.

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.

COMPENSATION:

The expected salary range for this position is $88,000 to $110,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.