The Senior Validation Engineer is a high-level position in the Validation department of FDBU. This position will directly report to the Associate Director of Manufacturing Technology & Support, but may also have a functional reporting relationship to a senior colleague on a project-to-project basis.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Work under minimal supervision on complex projects and may assist/direct less experienced peers (20%)
- Wide latitude for independent judgment (5%)
- Support capital projects by providing technical expertise (10%)
- Manage large complex engineering projects (10%)
- Demonstrate supervisory skills with outside contractors and consultants (5%)
- Apply engineering design principles (10%)
- Demonstrate production troubleshooting knowledge (10%)
- Support development of engineering and technology transfer policies (5%).
- Prepare and deliver presentations to external audiences (10%)
- Identify process improvements and implement (10%)
- Other duties as assigned (5%)
- The Senior Validation Engineer will be expected to attend all internal hands-on training for the SOP’s in the curriculum assigned to the position.
- Support transfer of multiple new clinical projects from Process Development through large scale manufacture:
- Provide technical support for Risk Assessments with an emphasis on the impact of each individual parameter on Critical Quality Attributes.
- Ensure equipment is capable of maintaining all unit operation parameters.
- Drive/own equipment and instrumentation changes required to meet unit operation parameters.
- Provide hands-on training of new technologies/equipment/methods to manufacturing technicians.
- Prior to product manufacture, ensure DCS recipes/Unicorn recipes meet the specific process requirements.
- Manage/own all equipment related deviations.
- Support of Process Performance Qualification (PPQ) campaigns:
- Provide technical support for Process Criticality Assessments.
- Write Equipment Validation Master Plans (EVMPs) and provide to the Process Validation Team. Address all client comments/concerns related to the EVMP and equipment qualification status.
- Ensure accurate trending of clinical batch parameters utilized for Normal Operating Ranges and Acceptable Operating Ranges.
- Provide on-floor manufacturing support during critical unit operations.
- Manage/own all equipment related deviations.
- Draft/Execute Installation and Operational Qualifications related to new equipment and to support equipment changes.
- Provide technical support for FAT and SAT related to new equipment (some travel may be required).
- Review and approval of process batch records related to the core principal of the Staff Validation Engineer (Upstream or Downstream unit operations).
- Document clear and concise rational for equipment changes, process deviation impact assessments, and CAPA using the Trackwise QMS (Quality Management System).
- BSc. degree or equivalent.
- Staff Validation Engineer is a high-level position in the Validation/Technical Operations department of FDBU, a minimum of ten years of GMP experience is required. Experience using electronic document management systems and Trackwise QMS Software is required.
- The Technical Operations department provides 24-hour support to manufacturing. Execution of activities will be required outside of core business hours.
The Major Equipment and Systems that are supported include:
- DCS manufactured by Asea Brown Boveri (ABB) and Emerson (DeltaV).
- Fermentation and Cell Culture reactors manufactured by Applikon and Braun.
- Recovery centrifuges manufactured by Westfalia, Alfa Laval and Carr.
- Recovery homogenizers manufactured by Niro Soavi.
- LPC Skids manufactured by GE Healthcare.
- UFDF/NFF Skids manufactured by Millipore and Pall.
- Single Use Equipment manufactured by various vendors, including Xcellerex (GE) and Sartorius.
Ability to work in a cross-functional team environment
- The Senior Validation Engineer works with multiple groups within FDB; including colleagues from all sites. These core groups include Manufacturing, Process Development, Process Sciences, Facilities, Automation Engineering, Quality Assurance, and Quality Control.
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.