Jamie Darragh

Phone: 774-***-**** / Email: ac67an@r.postjobfree.com / ac67an@r.postjobfree.com

Address; 29 Memorial Dr. East Bridgewater Mass. 02333

Summary

Active within the Biotechnology industry for 13 years and bringing experience with advanced training in Protein Purification, Cell Culture, OJT to Classroom led Training, SOP Technical Writing, Deviation Investigation, CAPA, Gap analysis, Small Molecule Synthesis, PCR Prototype Engineering, HPLC, NMR, Aseptic Techniques, MS Word, Excel, and PowerPoint.

An experienced, enthusiastic, and adaptive person within biotechnology and biopharmaceuticals with a focus on Quality, Safety, Technical Writing, Analysis, LIMS, Project Management, CQV, Document Control, TrackWise, PDOC, LiveLink and ETOP.

Skills

CQV Document Control

Automation Engineering LIMS

Validation Process Engineering

Instructor Led Training HPLC Analysis

Deviation Writing TrackWise

Research and Development SharePoint Administration

Engineering Support Technical Writing

Document Control PDOC

Quality Control Quality Assurance

SAP ETOP Management

Experience

Hyde Engineering & Consulting, CQV Consultant 3 Technical Writing

On-Site Gene Therapy Pfizer Sanford NC

November 2017- April 2018

Working in the New Gene Therapy Laboratory at Pfizer site writing new SOP Documents for Single Use Disposable Technology’s for Upstream, Downstream, Solutions Preparations and Utility’s.

Excel at working with subject-matter experts to gather information, identify relevant data and audiences, and write documents that are clear and user friendly.

Outstanding technical skills. Adept with formatting programs and content management systems.

Documents to be prepared within established timelines and in accordance with internal processes.

Provide updates to team with regard to content as appropriate, as well as processes and timelines.

Provide guidance and oversee the work of other medical writers, external contractors, and document specialists supporting a project.

Manage the work of document/project team members.

Work collaboratively in a team environment with minimal direction and take a proactive role on multiple assigned projects with respect to timing, scheduling, and tracking.

Excellent listening skills and am proficient at sending clear, convincing, and well-tuned messages to the QVC team.

Audit existing process flows.

Perform internal assessments to ensure the Quality Management System is effective and seek continuous improvement of the system.

Assist in the preparation of Quality System and metrics review on a regular basis.

Provides audit readiness and ongoing audit support including any corrective actions related to project issues.

Provides input into addressing non-conformances through analysis and providing recommendations for solutions including development/implementation of corrective actions.

Communicates changes to or the introduction of new controlled documents along with any required downstream document management and training activities.

Coaches/Trains users of the new process flows.

Wrote all Downstream and Upstream MBR’s for the production groups.

Hyde Engineering & Consulting, Validation Consultant

On-Site ETOP Manager QVC

April 2017 – September 2017

Worked at the NH site as a ETOP Manager for the CQV group.

Performing quality and constructability reviews of design documents

Perform the collection and organizing of Start Up and Commissioning completion and testing documents.

Provide initiation and management of the project punch list

Coordinate the assembly of Turnover documentation for requisition packages.

Validate the System Component List. Engineering to assign each component contained within a turn over system’

Coordinate with Engineering, QA, Materials Management, and Supervision as required to ensure that complete and accurate certifications in compliance with project requirements are generated, authenticated and processed.

Assist in closeout of site subcontracts through verification that finalized certification dossiers pertinent to that scope of work are available.

Generates reports from the Master Punch list by Turnover System Number of the remaining open items by craft and provide the reports to construction or commissioning and shown in the responsibility matrix’

Advise the Turnover and Construction Managers of any breakdowns or irregularities in the certification and reporting systems’

Compile the list of needed Certificates / Forms Matrix.

Perkin Elmer, Scientist 2 LEQ PM

Genzyme Framingham On-Site Consultant

March 2016 – June 2016

LEQ lead for HPLC qualifications.

This position is responsible for managing change controls associated with complex laboratory instruments as well as managing vendors and instrument associated documentation

Draft and obtain approvals for change control proposals and plans

Facilitate risk assessment and subject matter expert (SME) assessment meetings. Ensure all assessments are captured in the final change control plan.

Actively manage the change control in the Quality Management System (Trackwise Livelink or SharePoint

Obtain quotes and qualification documentation from vendors. Coordinate, schedule and manage qualification activities with vendors (e.g. PMs, IOQs etc)

Complete documentation associate with instrument implementation such as user requirements, calibration parameters, and preventative maintenance and operational SOPs.

Prepare allocated space in the laboratory for instrument implementations.

Support the team as a technical specialist for analytical instrument implementations such as HPLC, Dionex, GC, UVVis Spectroscopy and empower software.

Demonstrated knowledge of cGXP regulations and guidance

Genentech / Roche RCI, Engineering Turn Over Package

Val Spec On-Site Consultant

February 2015 – April 2015

QVC Engineering Turnover Package Manager for new facility in South Carolina.

Supply reports and contribute site system turnover meetings to update construction schedule.

Support CQC Manager to Schedule and participate in system walk down with all relevant personnel, with construction management input

Request detailed list of all system turnover close-out deliverables per contract from site and/or project management

Participate in the review of the following lists for completeness and accurate scoping, and provide feedback to Field Engineering and Commissioning Test Groups

Create Excel Equipment List

Create Excel Line List

Develop Asset Tag reviews with Finance and the Project Management team and adding tags to the EMMS Project Management

Verify system turnover package release dates are in project schedule and escalate as necessary

Attend reviews and evaluations of the system turnover package schedule to verify sequencing meets commissioning requirements

Associate ties to construction quality checklist required for quality installation of all components with direction from CQC Managers

Execute site specific system turnover process

Support CQC Manager with Coordinating the completion of items identified in work list / punch list

Maintain and report overall project system turnover status

Participating in walk downs and assuring identified open items are completed, punch listed, as appropriate

Genzyme, Automation Engineering Staff Assistant

Kaztronix On-Site Consultant

November 2012 – November 2013

Support Consent Decree for the Automation Engineering process at the Allston site.

Provide training to the Manufacturing personnel for the Emerson DeltaV and RS3 Process Control Systems

Worked with training group to develop DeltaV training standards

Support engineering data requests from other departments

Provide engineering documentation support to automation engineers

Manage engineering documents from approval through final mastering for engineering projects

Redline SOP’s for processing through document control

Support Automation Engineering group with all projects

Manages the document change control process, coordinating cross functional reviews, approvals and effective targets in alignment with requirement (cGMP. Consent Decree)

Authors new/revised documents and performance qualification in alignment with requirement for Consent Decree.

Provide floor support to troubleshoot DeltaV operator stations in the field

CAPA Gap Analysis

Work with Training and Development to build training curriculum for the Automation Engineering department

Technical writing for Small Project Engineering Packages for change controls within Manufacturing facility (FR, FRS, SOP, QVC docs ect.)

SharePoint Administrator for the Automation Engineering Department

Experienced with statistical methodologies, cGMP regulations, and regulatory requirements

Edit, standardize, or revise material prepared by other writers or subject matter experts.

Biogen Idec, Downstream Process and Validation

Kelly Services On-Site Consultant

August 2011 – June 2012

Downstream and Validation for the Pilot plant at Biogen Idec. Cambridge Mass.

Operated manual and automated purification skids.

Operated and troubleshot small equipment

Validated and Commissioned purification equipment

Wrote and revised process documentation

Assisted supervisor with leading day to day operations

Trained new and existing associates

CIP/SIP and assembled process equipment

Prepared media and buffers

Reviewed Batch Records

Sepracor, R & D Process Engineering Pilot Plant Technician

Kelly Services On-Site Consultant

August 2011 – June 2012

Lead Technician for the Process Engineering Pilot Plant for Kilo production of API and Commissioning activities at Sepracor Pharmaceuticals in Marlboro Mass.

Preformed chemical synthesis of various research compounds at kilo scale

Design and full build out a new Kilo Lab and start IQ/OQ and testing of equipment

Set-up, cleaning and maintenance of kilo lab reactors, pumps, filters, heater/chillers, Buchi

autoclaves, vacuum pumps and drying ovens, small Buchi and HEL high pressure reactors

HPLC sample preparation and analysis

Monitored real time chemical batches with the R&D team and chemists

Maintained and analyzed lab equipment, log book, and batch production records for QA.

Work independently to provide support on upstream/downstream facility fit, process technology transfer and process validation. Provide process troubleshooting during scale-up and engineering runs

I work effectively in highly cross-functional project teams, matrix management environments and working independently to accomplish project goals

Experience with statistical methodologies, cGMP regulations, and regulatory requirements

My duties included cross-functional meetings and professionally represent the Process Engineering team

United States Air Force, Transportation Department Maintenance and Commissioning

Airman 1st Class

1996 - 1999

Maintenance Technician and Commissioning agent with the USAF.

Education

Bridgewater State College, Bridgewater, MA

Chemistry/Business–2008-2011

1999 – 2002 (Incomplete)

Apollo College, Spokane, WA

Pharmacology/ Pharmacy Aseptic Controls

1999 – 2002

United States Air Force, Port Hueneme, California USN training SeeBee’s

Maintenance and Commissioning training

1996 - 1997

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