Bryllan LLC ยท 3 months ago
Associate Specialist, Validation
Brighton, MI
Contract
Onsite
Entry Level
2+ years expBryllan LLC is a company focused on pharmaceutical manufacturing, and they are seeking an Associate Specialist, Validation to support qualification activities for facilities, utilities, and equipment. This role involves executing test protocols to ensure systems meet regulatory requirements and collaborating with user departments to capture requirements.
Machinery ManufacturingManufacturingPharmaceuticalService Industry
Responsibilities
Support implementation of facility modifications, new utilities and new equipment by executing test protocols to ensure the systems are installed, operational and performing correctly
This includes safety testing, utility requirements, functionality testing, determination of operating ranges of critical process parameters, user access & control, establishing Preventative Maintenance plans, spare parts lists, calibrations, alarm response, etc
Author risk assessments to determine how much qualification testing is required on new systems
Summarize the capabilities of GMP systems controlled by a computer, to ensure that any system that generates data meets regulatory requirements
Perform periodic assessments of GMP systems to ensure that previous validation activities are updated to capture new regulatory requirements
Collaborate with the end user departments to ensure user requirements are captured prior to executing test protocols
Must be someone with a 'can do' attitude, eager to make a difference
Strong understanding & comprehension of English is required, as most work activities require significant documentation that must meet stringent regulatory requirements
Must be willing to work 'hands on' with equipment
Physical requirements include ladder use (ie, heights), lifting up to 20 pounds unassisted
Must be willing & able to wear appropriate PPE
Qualification
Required
Support implementation of facility modifications, new utilities and new equipment by executing test protocols to ensure the systems are installed, operational and performing correctly
Author risk assessments to determine how much qualification testing is required on new systems
Summarize the capabilities of GMP systems controlled by a computer, to ensure that any system that generates data meets regulatory requirements
Perform periodic assessments of GMP systems to ensure that previous validation activities are updated to capture new regulatory requirements
Collaborate with the end user departments to ensure user requirements are captured prior to executing test protocols
Must be someone with a 'can do' attitude, eager to make a difference
Strong understanding & comprehension of English is required, as most work activities require significant documentation that must meet stringent regulatory requirements
Must be willing to work 'hands on' with equipment
Physical requirements include ladder use (ie, heights), lifting up to 20 pounds unassisted
Must be willing & able to wear appropriate PPE
Strong work ethic and ability to accomplish tasks without supervision
Excellent interpersonal skills with the ability to cooperate with others in a high-performance setting
Strong mathematical and organizational skills
English communication skills, both written and verbal
Must possess honesty and integrity, commitment to the highest legal and ethical standards
Ability to treat every person with courtesy and respect
Demonstrate ownership and accountability to production schedule without compromising product quality
Desire to work with others and share best practices with colleagues on their shift and on other shifts
Knowledge of fundamental cGMP and regulatory principles
A Bachelor of Science in Engineering or equivalent is strongly preferred, or a minimum of 2 years of Validation experience
Company
Bryllan LLC
11-50 employees
H1B Sponsorship
Bryllan LLC 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
2022 (1)
Funding
Current Stage
Early StageRecent News
Crain's Detroit
2022-01-06
Company data provided by crunchbase