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Targeting Validation Engineer I
4625 NE Brookwood Pkwy Helvetia, OR 97124 US
Job Description
Main Purpose of the Position:
Under the direction of the PLANT Tech Transfer Validation Lead, the Validation Engineer will be accountable for supporting validation activities and validation change management system for validated equipment, utilities and facilities such as Critical Assessment (CA), System Impact Assessment (SIA), Requirements Trace Matrix (RTM), Data Integrity Assessment (DIA), User Requirements (URS) and protocol generations relevant to validation activities.
Responsibilities:
- Support the development, execution, and management of the timelines for the execution of CA/SIA/RTM/DIA/URS activities.
- Track and trend activities and report on issues such as impact to predetermined timelines and problems as needed.
- Support validation activities and 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.
- Assist with preparation and review of relevant sections of protocol generations/approvals processes.
- Serve as a representative on cross-functional and multi-site teams.
- Support development of formulation, filling, and packaging, area SOPs and manufacturing documents as appropriate.
- Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements.
Qualifications / Requirements:
- BS in chemical, biochemical engineering, or related field/experience, with a minimum of?2 years experience in process engineering, validation engineering, or Technical Services is required. No more than 2-5 years of exp. needed.
- Strong in Technical Writing.
- Cleaning and Sterilization qualification experience is a must.
- Experience in the pharma/biotech industry is a plus. Knowledge of cGMPs or equivalent regulations.
- Working knowledge of formulation, filling, inspection, and packaging equipment qualification in a regulated environment.
- Demonstrated understanding of project management skills.
- 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.
Pay Rate Range: 30-47/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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