1. TIMOTHY L. SUNDERLAND
6 Grove Street
Easton, PA 18045
(610) 252-4101
sunnutri@rcn.com
Validation  Project Management  Quality Assurance
Dedicated business professional with over 21 years experience in commercial validation and
quality assurance in pharmaceutical and biotechnology environments. A solid record of producing
high quality results and successfully applying in-depth knowledge of validation concepts and
techniques from both the manufacturing and service provider perspective. Areas of expertise
include the following:
 cGMPs  IQ/OQ/PQ Protocols  Aseptic Manufacturing
 Environmental Monitoring  Regulatory Compliance  Calibration
 Equipment Qualifications  System Qualifications
QUALIFICATION HIGHLIGHTS
⇒ Extensive experience in all phases of the validation process including authoring and
executing IQ/OQ/PQ protocols, resolving deviations, conducting data integrity reviews, writing
summary reports and coordinating all approvals.
⇒ Adept at managing multiple validation projects simultaneously and maintaining ongoing
communication with vendors, manufacturers, engineers, end-users and all levels of
management.
⇒ Created new validation department for a medical device manufacturer and for a validation
services company supporting multiple cGMP customers. Developed SOPs, mission
statements, and job descriptions. Specified and purchased equipment, wrote/executed
validation protocols and created summary reports.
INDUSTRY EXPERIENCE
Micro-Clean, Inc., Bethlehem, PA
Validation Specialist II
2010 - present
• Perform validation studies for a wide variety of facilities and equipment in the pharmaceutical
and biotechnology industries.
• Write and execute validation protocols and create summary reports for various equipment
types critical to the customer’s laboratory and cGMP manufacturing environments using:
environmental monitoring equipment, calibration test instrumentation, and temperature and
relative humidity monitoring equipment.
• Conduct extensive hands-on and classroom training on equipment and process-specific
procedures, test instrumentation, and competency based training.

2. TIMOTHY L. SUNDERLAND PAGE 2
Micro-Clean, Inc., Bethlehem, PA
Senior Validation Project Manager 2000-2006
• Managed validation projects and supervised other validation analysts as required.
• Conducted QA review of validation protocols. Test plans and summary reports.
• Maintained responsibility for teams designing protocols, monitoring studies and writing final
reports.
• Provided QA expertise as a resource to identify gaps, facilitate remedial actions and ensure
they were resolved in a compliant manner.
• Partnered with engineer, manufacturing and other technical staff to ensure that all test
functions were verified.
Micro-Clean, Inc., Bethlehem, PA
Validation Department Manager 1995 - 2000
• Created new Validation Department including development of mission statement, SOPs and
job descriptions. Developed business contacts to establish new project opportunities.
• Wrote and executed validation protocols, managed projects, authored final reports and
supervised employees.
Osteotech, Inc., Shrewsbury, NJ
Validation Department Manager 1994 – 1995
• Created new Validation Department, developed validation protocols and summary reports.
Raytheon Engineers and Constructors, Philadelphia, PA
Validation Specialist
1992 – 1994
• Worked on project team which authored and reviewed equipment & validation protocols for
pharmaceutical and biotechnology customers. Executed autoclave, oven and HVAC protocols
and created reports on regulatory/compliance matters for clients.
Hoechst-Roussel Pharmaceuticals, Somerville, NJ
QA Microbiologist II 1988 – 1992
• Performed microscopic analysis of customer complaints and testing of routine QC samples.
Directed media fills and coordinated microbiological support studies. Performed qualification
studies for autoclaves, dry heat ovens and depyrogenation tunnels.
Elkins-Sinn, Inc., Cherry Hill, NJ
Validation/Environmental Monitoring Technician 1987 – 1988
• Environmental monitoring technician in aseptic SVP manufacturing areas.
OTHER EMPLOYMENT
Lehigh Valley Grace Brethren Church, Bethlehem, PA
Assistant Pastor 2006 – 2010

3. TIMOTHY L. SUNDERLAND PAGE 3
EDUCATION AND COMPUTER SKILLS
Bachelor of Science, Biology, Juniata College, Huntingdon, PA, 1986 (GPA: 3.41)
Master of Divinity, Biblical Theological Seminary, Hatfield, PA, 2007 (GPA: 3.61)
Computer Skills – Proficient in Microsoft Office Word, Excel, and Outlook
ADDITIONAL COMPETENCIES
 Cleanrooms  USP <797> Environments  Utilities
 Isolators  ISO 8573 Compressed Air
Testing
 HVAC Systems
 Biological Safety Cabinets  Computer-Automated
Equipment
 Building Automation/
Monitoring Systems