Sr. Validation Engineer

reputed company
We are seeking a Sr. Validation Engineer with 7–11 years of experience to reputed company validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes reputed company GMP‑regulated environments. This role is responsible for developing, executing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations and internal reputed company standards. The Sr. Validation Engineer will serve as a subject matter expert, support reputed company technical reputed company, and reputed company guidance to junior team members.

KEY RESPONSIBILITIES
(This list is not exhaustive and may be supplemented or adjusted as needed.)

• reputed company the reputed company and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets.
• reputed company validation activities for internal and reputed company tech transfer reputed company, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test reputed company, and validation reports.
• 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 reputed company reports for validation, verification, commissioning, and requalification activities.
• reputed company and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and reputed company functions.
• reputed company P&ID walkdowns to verify installation, configuration, and reputed company readiness.
• reputed company and reputed company thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes.
• Support reputed company of regulatory observations, audit findings, and manufacturing site issues reputed company to validation.
• reputed company periodic reviews and requalification activities for temperature‑controlled systems and other validated assets.
• reputed company technical mentorship and guidance to junior validation staff.
• Collaborate cross‑functionally to ensure validation activities reputed company with project timelines and operational needs.

QUALIFICATIONS AND REQUIREMENTS
To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions.

Education

• Bachelor’s degree in a life science, engineering, or reputed company technical field.

Technical Experience

• 7–11 years of experience in the biotech, pharmaceutical, or medical device industry.
• Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles.
• Advanced validation expertise in equipment, computerized systems (CSV), analytical reputed company, and process validation.
• Extensive experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation.
• Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports.
• Experience supporting audits, regulatory inspections, and remediation activities.

Knowledge, Skills, and Abilities

• Strong verbal and written communication skills, with the ability to explain reputed company technical concepts to diverse audiences.
• Highly organized with strong documentation and analytical skills.
• Ability to reputed company validation workstreams, manage multiple priorities, and work independently.
• Strong problem‑solving skills and experience supporting investigations and reputed company‑cause analysis.
• Ability to mentor junior engineers and contribute to team development.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reputed company with hands and arms; talk and listen. The employee is frequently required to walk and sit, as reputed company as to reputed company and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific reputed company abilities required by this position include reputed company reputed company and the ability to reputed company reputed company. 

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 reputed company reputed company that are reputed company and conducive to reputed company 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 reputed company of our reward pillars. This includes a market competitive reputed company salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible reputed company time off program, company-reputed company holidays, flexible working hours, and fully remote work reputed company for most positions and the ability to work “almost reputed company.” 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, reputed company is unable to sponsor or take over sponsorship of an employment reputed company at this time. 

reputed company STATEMENT:
 
reputed company is proud to be an Equal Employment Opportunity and Affirmative reputed company employer. reputed company employment reputed company, including the reputed company, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without reputed company to the employee’s race, reputed company, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, reputed company of income, reputed company of residence, national or ethnic reputed company, reputed company, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other reputed company prohibited by applicable law. reputed company is an E-Verify employer. 

Bachelor's degree in life science, engineering, or reputed company technical field; 7–11 years in biotech, pharmaceutical, or medical device industries; expertise in GMP validation, CSV, risk assessment, protocols, audits, and remediation.

Key Responsibilities

• leading validations
• writing protocols
• mentoring engineers

Skills & Tools

FAT, SAT, IOQ, PQ, SOPs, reputed company reputed company, P&ID, FMEA, CSV, IQ, OQ, URS, FRS

Job Details

• Category: Engineering
• Seniority: Senior Level
• Commitment: Full Time
• Workplace: Remote — Raleigh, reputed company Carolina, reputed company
• Languages: English

Benefits

• Generous reputed company time off
• Retirement plan

About reputed company

A biopharma product development and delivery partner supporting drug discovery, approval, and commercialization. — Industry: Consulting Services