Validation Engineer

Initial Therapeutics, Inc.; Boston (MA); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Flexible paid time off

Company paid holidays

Fully remote work options

Job summary

Initial Therapeutics, Inc. in Boston is hiring a Validation Engineer to create and execute validation protocols. This role includes ensuring overall quality compliance and supporting technical documentation for validation activities.

The ideal candidate will have a Bachelor’s degree in a life science field and 3-10 years of experience in the biotech industry. Strong communication skills and knowledge of FDA regulations are essential for success.

Qualifications

• 3-10 years of experience in the biotech, pharmaceutical, or medical device industry.
• Experience with FDA regulations.
• Expertise in validation protocols.

Responsibilities

• Develop and execute validation protocols.
• Support validation activities for projects.
• Write and review technical documentation.

Skills

Strong verbal and written communication skills

Knowledge of FDA cGMP, FMEA, Risk Analysis

Validation expertise in Equipment, CSV, Method, and Process

Report writing for IQ, OQ, PQ, and CSV

Education

Bachelor’s degree in a related life science field

Job description

Syner-G is seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program.

Key Responsibilities

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

• Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification.
• Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR).
• Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
• Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
• Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments.
• Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
• Support the resolution of regulatory observations or manufacturing site issues.
• Execute periodic reviews and requalification for temperature chambers.

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

• 3-10 years of experience within the biotech, pharmaceutical, or medical device industry.
• Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required.
• Validation expertise in Equipment, CSV, Method, and Process.
• Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation.
• Report writing experience for IQ, OQ, PQ, and CSV.

Knowledge, Skills, and Abilities

• Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired.

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.