Validation Engineer

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:

• Bachelor’s degree in a related life science field.

Technical Experience:

• 5 – 7 years of experience within the biotech, pharmaceutical, or medical device industry.
• Knowledge and experience working with FDA, cGMP, FMEA, Risk Analysis, and spreadsheet validation.
• Validation expertise in Equipment, CSV (Computer System Validation), Method, and Process disciplines.
• Protocol generation experience with an emphasis on computerized equipment and systems validation of automated production systems.
• Extensive experience writing validation and supporting documentation plus reporting for CQV and CSV.

Knowledge, Skills, and Abilities:

• Strong leadership skills with the ability to lead a small project team of CQV engineers.
• Willingness to travel up to 100% for projects at client sites.

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:

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.