For more than 20 years, Trinity Consultants has assisted facilities in the aerospace industry with regulatory compliance and environmental management issues. Trinity has a long history of assisting facilities with their regulatory compliance and environmental management systems. Trinity helps chemical and pharmaceutical manufacturers to achieve regulatory and environmental compliance. Due to their nature, general manufacturing facilities are often faced with reviewing a wide range of regulations to determine applicability. Trinity provides a variety of services to government entities, including environmental permitting and compliance management. Trinity Consultants has long been committed to assisting lime and aggregates facilities with their regulatory compliance needs. Trinity takes pride in understanding the regulatory issues affecting our clients facilities and their industry. Oil and gas facilities must contend with a variety of regulatory compliance and environmental management demands. Trinity Consultants has long been committed to assisting cement facilities with their regulatory compliance and environmental management needs. Trinity has extensive experience assisting the pulp and paper industry with its regulatory compliance and environmental management requirements. Railroads are faced with rapidly evolving state, regional, and federal regulatory framework in the United States. Trinity prepares hundreds of air quality compliance reports for landfills and industrial facilities across the United States on an annual basis. For nearly 30 years, Trinity Consultants has assisted facilities such as those in the highly regulated wood products industry. The June 2016 Lautenberg amendments to the Toxic Substances Control Act (TSCA) required EPA to improve the TSCA Inventory by identifying which \"chemical substances\" are actively in commerce in the United States, allowing the agency to better The Regional Haze Rule (RHR) establishes a comprehensive visibility protection program for Class I areas and requires states to set reasonable progress goals (RPGs) towards achieving natural visibility conditions in all Class I areas by 2064. EPA In January 2019, Trinity Consultants (Trinity) acquired The Redstone Group (Redstone), a consulting services provider of international chemical control laws, and EHS auditing, compliance and permitting.Redstone has deep expertise and advises clients In 2016, the U.S. Customs and Border Protection (CBP) revised its importer compliance monitoring approach, although the change garnered little press. The agency's new priority involves re-focusing existing resources and using methods that more Leak Detection and Repair (LDAR) involves finding facility components that are leaking and fixing them. The U.S. Environmental Protection Agency (EPA) has a long history of regulating industries (such as petroleum refining and chemical View our monthly digests of environmental regulatory actions published in the U.S. Federal Register, with hyperlinks to the complete Federal Register notices. all summaries from 2011 These papers, presentations, and articles were authored by the staff of Trinity Consultants for presentation at various conferences. all papers & presentations View recorded webinars on important regulatory developments and their implications for the regulated community. all videos Since its founding in 1974, Trinity has expanded its geographic footprint and breadth of services. We attribute our continued growth to a focus on cornerstone values of top-notch technical performance and excellence in client service. ADVENT Engineering, a Trinity Consultants company, is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern US, Midwest, Gulf Coast, and Canada, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects. ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies. The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, compliance mindset, commissioning/qualification skills, and technical writing are the desired skill set. This is an outstanding opportunity to join our growing team! Positions available in multiple U.S. locations - North Carolina, Boston, San Francisco Bay Area, Texas, etc. Responsibilities Utilize engineering, vendor, and client specifications to generate and execute testing protocols for process equipment and utility systems following client procedures and good documentation practices Assist in deviation root cause analysis and corrective action plans Generate final and summary reports for executed test protocols Provide technical and compliance input into project execution strategies to ensure regulatory requirements are met. Generate and support higher level project documentation as required such as Masterplans, schedules, and summary reports. Working in the full range of Biotech/pharma project phase execution including all design phases, construction, startup, CQV, and project hand-over activities. You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and ADVENT resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc. Qualifications 5 to 20+ years of experience in biotech, pharmaceutical, medical device, or academic or environment Experience writing and executing commissioning, verification, and validation protocols and associated reports Familiar with integrated commissioning and validation as well as ASTM E2500 verification methods Experience utilizing risk based methodologies in testing Experience with manufacturing processes and equipment such as CIP/COP systems, filtration skids, chromatography, fermentors/bioreactors, sterilization, and lyophilization equipment Experience with hygienic utility systems such as purified water, WFI, clean steam, and process air Experienced with Office software such as Word and Excel Experience with testing equipment and software such as Kaye Validators and Dataloggers Engineering or Scientific degree Travel may be required on occasion Permanent FTE or temporary/contract options available Candidates, please note: Kindly ONLY apply if you meet the experience expectations described. Experience in GMP pharmaceutical and/or biotechnology facilities in design, engineering, quality or manufacturing is a MUST. Candidates with direct related experience interested in US or Toronto locations are encouraged to apply. Associated topics: biochemistry, bioinformatic, biological engineer, bioprocessing, genetic, neuro, nutrition, parenteral, pharmaceutical, therapeutic
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.