Validation Engineer

Job Description

Job Description

COMPANY DESCRIPTION

Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum.

We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale and quality of life-saving innovations.

We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery, approval, product development, technology transfer and commercial manufacturing process. We also equip our partners with the tools, knowledge and expertise to streamline operations, enhance quality and ensure compliance.

Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G and Sequoia, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit www.Sequoiabiotech.com / or www.Synergbiopharma.com

POSITION OVERVIEW :

We are seeking a Validation Engineer to assist with the development and execution of validation protocols for various processes. The Validation Engineer will be responsible for driving quality, performance, and overall compliance throughout the organization. This role includes the ability to lead a small project team of CQV (Commissioning, Qualification, and Validation) engineers.

KEY RESPONSIBILITIES :

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

• Perform equipment qualifications including Commissioning, IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
• Travel to various client sites to provide validation services.
• Write, review, approve, and execute validation protocols.
• Create reports summarizing results and statistics.
• Develop and communicate expectations for quality performance, continuous improvement, and quality systems.
• Assist developers and domain experts in designing, performing, and improving verification tests.
• Ensure the validation program meets GMP (Good Manufacturing Practice), FDA, and ISO regulations.
• Work with scientists, technicians, engineers, and project management to deliver equipment and facilities into a validated state.
• Interact with cross-disciplinary teams to meet project milestones and end goals.
• Collaborate with key stakeholders and client teams to define needs and achievable solutions and / or justifications for equipment requirements and related validation.
• Lead and mentor a small project team of CQV engineers.

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 :

Technical Experience :

Knowledge, Skills, and Abilities :

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.

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 :

Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $88,423.04 yearly in our lowest geographic market up to $125,935.84 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

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.

LEGAL STATEMENT

Syner-G BioPharma Group and Sequoia Biotech Consulting are proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.

Salary : $88,423 - $125,936