Equipment Validation Engineer jobs in United States
cer-icon
Apply on Employer Site
company-logo

PharmEng Technology ยท 2 weeks ago

Equipment Validation Engineer

positionPortsmouth, NH
timeFull-time
remoteOnsite
senioritySenior Level
date7+ years exp

PharmEng Technology is seeking an Equipment Validation Engineer who ensures all critical GMP equipment and systems are validated and maintained in compliance with user requirements and global regulatory guidelines. The role involves providing documented evidence to support validation activities while collaborating with various departments to maintain a compliant manufacturing environment.

ConsultingInformation TechnologyPharmaceutical
check
H1B Sponsor Likelynote

Responsibilities

Ensure validation of all critical GMP equipment and systems in accordance with user requirements and process parameters
Maintain compliance with global regulatory guidelines and industry best practices
Develop and execute validation protocols and reports for equipment and systems
Provide scientifically sound, documented evidence to support validation activities
Collaborate with Operations, Quality Assurance, and regulatory bodies to ensure validation requirements are met
Conduct risk assessments and identify potential validation issues
Troubleshoot and resolve validation-related problems in a timely manner
Maintain accurate and comprehensive documentation of validation activities
Provide training and support to junior team members and other departments as needed

Qualification

GMP regulationsEquipment validationAnalytical skillsProblem-solving skillsCommunication skillsInterpersonal skillsAttention to detail

Required

Bachelor's degree in Engineering, Chemistry, or a related field
Minimum of 7 years of experience in equipment validation or a related field
Strong understanding of GMP regulations and validation principles
Excellent analytical and problem-solving skills
Strong attention to detail and ability to work independently and as part of a team
Effective communication and interpersonal skills

Preferred

Master's degree in Engineering, Chemistry, or a related field
Experience with validation of equipment in a regulated manufacturing environment
Knowledge of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP)

Company

PharmEng Technology

twittertwittertwitter
company-logo
PharmEng Technology is a pharmaceutical company that provides consultancy services.
dateFounded in 1997
location
Toronto, Ontario, CAN
people-size201-500 employees
web-link
http://pharmeng.com

H1B Sponsorship

PharmEng Technology has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2022 (1)

Funding

Current Stage
Growth Stage

Leadership Team

leader-logo
Alan Kwong
Managing Director & CEO
linkedin
Company data provided by crunchbase