Scott Theriault Email & Phone Number

Pottstown, Pa, Us

Malvern, Pa, Us

• Management of Engineering team and mentor on current projects / career development• Demonstrated ability to innovate and proactively address evolving technical challenges• Ability to work in a fluid environment, manage time efficiently, achieve goals with minimal supervision and effectively interact with other employees, departments, service providers and development & manufacturing partners• Ability to manage multiple projects, prioritize workload, meet deadlines while maintaining a high level of quality and accuracy• Led, developed, and collaborated with cross-functional teams in new product launches, technology transfers, cost & process improvements, systems development & installations, etc• Liaison/back-up for Facilities Manager and participate in facilities activities where necessary• Sole packaging engineer responsible for all products’ packaging requirements including package design & development, integrity, sterilization, stability, distribution, etc.• Developed multiple innovative packaging systems, one of which led to filing a provisional patent, due to a brand new sterilization method• Actively participated and continue to contribute in all product launches, including the first at TELA Bio• Led many CAPAs, NCRs, Change Controls and Investigations• Closely worked with manufacturing partners, external vendors, Product Development, Operations, Marketing, Quality, and top management on a daily basis• Permanent member of the Safety Committee and actively participates in all EHS activities• Active member of the validation and equipment teams• Helped lead the development and implementation of completely overhauled equipment control and validation programs to further gain compliance with regulatory requirements and industry standards

Us

• Participated in Verification meetings for Consent Decree Workstep completion• Aided in the organization and administration of Shipping Qualification remediation for Consent Decree.• Worked closely with cross-functional teams both internally and with external sites. • Aided in the development of SOPs for new requirements as related to Consent Decree.• Developed protocols, reports and other documentation for Consent Decree remediation work.• Developed Quality Risk Management documentation for Consent Decree remediation work.• Developed and maintained Metric documentation to evaluate Consent Decree remediation.• Executed Shipping Qualification protocols for Consent Decree remediation.• Developed testing bracketing strategies and other testing position papers for Consent Decree remediation.• Dealt with FDA regulations daily in packaging, testing, and manufacturing procedures. • Worked under current Good Manufacturing Practices (cGMP) regularly.

Chester Springs, Pa, Us

www.apsol.uswww.noriskconsulting.com With the global marketplace continuing to be extremely challenging, supply chain efficiency is becoming increasingly important. One of the most overlooked, but arguably, one of the most important aspects of a company's supply chain is Package Engineering. Inefficiencies in this area of your business will most likely result in overwhelming occurrences in field damage, customer satisfaction issues, and/or millions of dollars in unnecessary packaging and shipping costs. The engineering staff at Advanced Packaging Solutions LLC (APS) has saved companies $$$ millions of dollars in supply chain costs with our diverse background in package engineering solutions for all industries. APS will consistantly deliver a beneficial solutions, while taking your company's unique requirements into consideration.

Cambridge, Cambridgeshire, Gb

• Managed product launch cross-functional teams while leading the installation and validation of new packaging line systems• Created and executed many installation, developmental and operational protocols for various packaging equipment including, but not limited to: blister formers/sealers, bottle fillers (slat, vibration, etc), vision systems, cartoners, tray loaders, case packers, etc• Performed cleaning validations for new products• Decommissioned equipment and computerized systems for removal from service• Developed a standardized developmental protocol template• Specification creation and maintenance • Aided in the management and execution of a large, site-wide cost improvement projects• Executed computer and equipment validation and commissioning work including, but not limited to: site card access system, air handling unit, USP water system, temperature monitoring system, building utilities alarm system, warehousing crane system, tablet coating system, tooling management system, etc.• Executed formulations equipment and tablet batch validation work

New York, New York, Us

• Aided in the deployment of a global specification system integrated with SAP - Integration and PQ testing- Developed PQ scripts - Helped others learn the new system as a super user - Prepared current specifications for data migration - Aided OTC, Bios, Rx, and Cold Chain groups prepare for transition• Specification and Bill of Material editing and development • Package test protocol and technical report development • Development of new package designs to present to Marketing • Coordinated with manufacturing facilities, suppliers and test laboratories • Assisted in new product launches • Constant use of cGMP practices and FDA regulatory guidelines

Lawrence Township, Nj, Us

• Project management of cost improvement, package testing, and package development projects • Package test development• Package testing lead• Constant use of cGMP practices and FDA regulatory guidelines

New Brunswick, Nj, Us

• Project management from start to finish in cost improvement and base business projects - Typically managed over fifteen projects at a time - Wide range of project types from consumer products to a class II medical device• Specification maintenance and development• Experience with PET, HDPE, & PVC bottles; closures; pumps; spray pumps; pouches; Jars; tubes & seamed tubes; IML, pressure sensitive, screen printed, & heat transfer labels; over-wrap; shrink film; and shippers• Prescribed package testing for team oriented projects• Manufacturing site leader for packaging engineering• Constant use of cGMP practices and FDA regulatory guidelines

• Specification and Bill of Material editing and development • Package test protocol execution and technical report development • Aided in development of new package designs to present to Marketing • Coordinated with manufacturing facilities, suppliers and test laboratories • Constant use of cGMP practices and FDA regulatory guidelines

Us

• Setup of a new database system Laboratory Information Management System (LIMS). • Advising/training new co-ops. • Brainstorming new ideas for testing, test fixtures, and test procedures. • Participated in packaging R&D involving testing procedures, packaging line trials, and technical documentation for primary, secondary, and tertiary packaging development. • Packaging included: blister packs, plastic bottles/closures, paper/plastic/aluminum pouches. • Major package testing procedures included: torque testing, distribution testing, package integrity testing, rub testing (i.e. smudge test), stability testing, water vapor and oxygen transmission rate testing, dosage line placement studies, equipment variability studies, and child/senior protocol testing. • Closely involved with Packaging Operations dealing with on and off site manufacturing. • Set up production lines at various production sites to ensure quality packaging. • Interacted with packaging specifications on a daily basis. • Developed strong technical writing ability through preparing reports, memos, e-mails, letters, and other forms of technical documentation. • Dealt with FDA regulations daily in packaging, testing, and manufacturing procedures. • Worked under current Good Manufacturing Practices (cGMP) regularly.

Us

• Participated in packaging R&D involving testing procedures, packaging line trials, and technical documentation for primary, secondary, and tertiary packaging development. • Packaging included: blister packs, plastic bottles/closures, paper/plastic/aluminum pouches. • Major package testing procedures included: torque testing, distribution testing, package integrity testing, rub testing (i.e. smudge test), stability testing, water vapor and oxygen transmission rate testing, dosage line placement studies, equipment variability studies, and child/senior protocol testing.• Dealt with FDA regulations daily in packaging, testing, and manufacturing procedures. • Worked under current Good Manufacturing Practices (cGMP) regularly.

Bachelor Of Applied Science (B.A.Sc.), Packaging Engineering

Regents Diploma, Technical Concentration