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Senior Validation Engineer
1 month ago
Title: Senior Validation Engineer
Location: Hillsboro OR , 97124
Duration: 3+ months
Job Description:
The Senior Validation Engineer will be accountable for performing validation activities such as Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV) / Process Validation (PV) and Revalidation (RV).
Responsibilities:
- Develop and manage the detailed project plans and timelines for the execution of validation activities.
- Prepare validation & change control documentation, including protocols, summary reports, etc., for validation activities.
- Lead the execution of CD/PQ/CV/PV/RV activities.
- Act as project manager for validation deliverables ensuring new systems are implemented within predetermined timelines and financial forecasts.
- Track and trend activities and report on issues such as impact to predetermined timelines and problems as needed.
- Provide input into investigations with potential validation impact.
- Coordinate the collection, testing and analysis of samples and reporting of results required per validation protocol.
- Support the change management system for validated equipment, utilities and facilities.
- Support the development of manufacturing documents as appropriate.
Qualifications / Requirements:
- BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 8 years with a BS (6 years with MS) experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services is required
- Experience in the pharma/biotech industry is required.
- Experience with cleaning and sterilization validation is required. Candidate must demonstrate understanding of cleaning and sterilization qualification requirements in cGMP environment.
- Demonstrated project management skills.
- Experience authoring, reviewing, and executing validation protocols.
- Knowledge of cGMPs or equivalent regulations.
- Working knowledge of formulation, filling, and, packaging, equipment qualification in a regulated environment is required.
- Ability to work with internal teams, partners, suppliers and customers.
- Operational excellence and industrial engineering skills are a plus.
- Professional level written and oral communication skills.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $55.32/hr.
