Skip to main content
REMOTERA
Back to feed
Syner-G

Sr. Validation Engineer

RemoteUnited States only
Published
Experience
Senior
Employment
Full-time
$114k–$137k/yr
Check eligibility

Open to US only. Set where you work from to check your eligibility.

No BS summary

Senior validation engineer with 7–11 years in biotech, pharmaceutical, or medical device GMP environments. Must know FDA cGMP, FMEA, risk-based validation, CSV, IQ/OQ/PQ, audits, and validation lifecycle documentation. US-based role; visa sponsorship is not available.

Core skills

CSVValidation lifecycle documentationGMP validation

Required skills

FDA cGMPFMEAIQOQPQFATSATIOQSOPURSFRSP&IDSIP

What you'll do

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

What they require

  • 7–11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP-regulated environments.
  • Bachelor’s degree in a life science, engineering, or related technical field.
  • 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 methods, 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.
  • Strong verbal and written communication skills, with the ability to explain complex technical concepts to diverse audiences.
  • Highly organized with strong documentation and analytical skills.
  • Ability to lead validation workstreams, manage multiple priorities, and work independently.
  • Strong problem-solving skills and experience supporting investigations and root-cause analysis.
  • Ability to mentor junior engineers and contribute to team development.
  • 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.
  • Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.
  • Syner-G is an E-Verify employer.

Benefits

  • Market competitive base salary
  • Annual incentive plan
  • Robust benefit offerings
  • Ongoing recognition and career development opportunities
  • Generous flexible paid time off program
  • Company-paid holidays
  • Flexible working hours
  • Fully remote work options for most positions
  • Ability to work “almost anywhere”
  • Office locations in Greater Boston; San Diego, CA; Boulder, CO; and India

Syner-G

Syner-G is a strategic biopharma product development and delivery partner supporting clients from drug discovery and approval through commercialization.

Biopharma

Details

Visa sponsorshipNo
Apply routeGreenhouse
$114k–$137k/yr