Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), No eye contacts allowed; prescriptive glasses will be provided, Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Excellent Benefits Package

Review our company’s Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement – eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Location/Division Specific Information

Middletown, VA

Hours: 8am - 5pm Mon-Fri

Summary: 

Working with PM/APM/Project Teams, support daily operations of Building 800 per regulatory and cGMP guidelines while coordinating manufacturing, cleaning, and maintenance related activities of manufacturing. 

 

Job description:   

Administer batch records to include SAP confirmations and batch record review.

Handle change requests from submission to close-out.  Ensure implemented changes meet objectives. 

Enter and complete deviation assessments. 

Assist in the resolution of manufacturing discrepancies and manufacturing product investigations by evaluating data and defining possible Corrective and Preventative actions (CAPAs). 

Assist and support the implementation of Engineering projects. 

Support the execution and review of engineering/validation-related documents including commissioning and IQ, OQ and PQ. 

Facilitate cleaning execution activities to ensure minimal equipment downtime while adhering to regulatory compliance. 

Plan/schedule cleaning solvent deliveries/disposal, cleaning reconfiguration, procedure training and cleaning execution in coordination with Logistics, EH&S, MSAT, and Quality. 

Perform manufacturing area maintenance management to include submission of notifications, planning/scheduling and follow up to ensure accurate completion of work. 

Issue and audit work permits to ensure compliance and safety procedures. 

Create Manufacturing Batch Records (MBR) and perform updates as needed. 

Provide technical feedback to solve process and equipment problems and support continuous improvement projects. 

Participate in and provide technical information to manufacturing Quality Risk Assessments (QRAs), Root Cause Analysis (RCA) and Process Hazard Analysis (PHAs). 

Evaluate automation changes and verify automation downloads. 

Ensure proper inventory management of raw materials and operating supplies. 

Assist with cycle counting and physical inventory requirements.  Perform inventory reconciliation, as required. 

Provides Instructor Led Training on procedures, techniques, and processes.

Administer, document and maintain the Patheon Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of Trackwise and available Quality Systems tools, as well as direct actions.

Perform lubrication walk downs. 

Perform document updates in Patheon’s Quality Systems. 

Review as-build P&IDs.

Prepare equipment pressure test packages. 

Perform other duties as required. 

 

Education: 

High School Diploma or equivalent and successful completion of Phases I-IV of the Process Tech Training Program or equivalent related work experience. 

 

Experience: 

Minimum of 2 years of related experience.

Requires extensive knowledge of PCR-2 automation systems and concepts, chemical manufacturing equipment and pharmaceutical cGMP operations.  Solid knowledge of Maintenance, Logistics, EH&S and Quality functions.