Sharp Sterile Manufacturing · 3 hours ago
Engineering Compliance Specialist
Lee, MA, US
Full-time
Onsite
Entry Level
$60K/yr - $90K/yr
1+ years expSharp Sterile Manufacturing is seeking an Engineering Compliance Specialist who will be responsible for overseeing and managing the investigation and timely closure of equipment deviations and records review processes. This role involves collaboration with various departments to ensure compliance with established procedures and support continuous improvements.
BiopharmaBiotechnologyHealth CareLife Science
Responsibilities
Manage the timely review and investigation of equipment-related deviations and respond to equipment record queries from internal / external sources
Oversee timely completion of any required Engineering-related corrections within quality events in accordance with the procedural requirements
Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause
Assist with implementation and supporting on-going continuous improvements
Follow up with Deviation/CAPA owners to make sure all new Deviations/CAPA's are completed on time in accordance with batch release schedule
Prepare and publish weekly departmental metrics
Interface with Quality, Materials, Manufacturing, Project Management and Maintenance personnel to accomplish department performance objectives
Participate or provide ownership of CAPA related to engineering or equipment
Contribute to development and validation of process improvements, SOPs, and staff training
Assist in compiling information for the Key Performance Indicators (KPI) on an as needed basis
Attend and complete all mandatory training
Oversee and participate in the recruitment and selection and successful onboarding of department staff
Demonstrate BSM values and behaviors at all times
Other duties as assigned
Support Quality Assurance investigation function during FDA, corporate GMPs and customers compliance audits
Participate in internal audits as applicable
Provide leadership in daily operations and have employees incorporate these compliance practices into their daily routines
Qualification
Required
One (1) year of relevant post-degree work experience in a laboratory, cGMP or quality position
Associates degree in a related field
Proficient in the use of MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat
Basic understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
Familiarity of engineering concepts
Time management
Attention to detail while executing multiple tasks
Well-organized
Good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills
Frequent standing and walking throughout the facility
Satisfactory audio-visual acuity
Company
Sharp Sterile Manufacturing
Sharp Sterile (formerly Berkshire Sterile Manufacturing) provides the safest sterile drug products for clinical use and small scale requirements through the use of modern technology, 100% isolator-based filling lines, and a skilled staff.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$2MKey Investors
MassDevelopment
2023-10-05Acquired
2018-07-17Debt Financing· $2M
Recent News
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