As a senior Process Validation Engineer, the candidate will support various technical and manufacturing activities during the process validation stage of manufacturing.
– Conduct process validation studies in accordance with current industry standards and guidelines for the qualification and validation of manufacturing systems and supporting processes.
– Develop qualification and validation protocols for manufacturing processes, systems and equipment such as filtration units, chromatography columns, automation controls, utilities, clean rooms, temperature-controlled areas, pasteurizers, lyopholizers, etc.
– Execute approved studies and protocols to gather data.
– Analyze the resulting data and develop the final validation report.
– Responsible for completion of studies within validation project time lines. Assists in the development of the time lines and communicates project updates within the validation department.
– Investigate and document all validation related deviations and determine assignable cause.
– Maintain current knowledge of regulatory and industry standards.
– Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
– Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
– Strict adherence to procedures and practices according to FDA regulations.
– Strong emphasis on documentation according to FDA regulations.
– Working closely with subject matter experts (SME) to generate validation documents compliant with the site policies and procedures
– Ensure proper execution/documentation of test results, and compilation of validation packages.
– Retrieve and compile data from electronic sources / databases and paper records
– Analyze data
– Responsible for authoring, reviewing, executing and approving validation documents
– Assist in writing Standard Work Instructions and Batch Production Records
– Assist in the development of manufacturing control strategies, methods and techniques.
– Maintain process compliance integrity by adhering to standard operating procedures (SOP’s) and current good manufacturing practices (cGMP).
– Adhere to departmental corporate safety policies.
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
– Bachelor’s degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field; 5 +years relevant experience and/or training or equivalent combination of education and experience.
– Knowledge and at least 3 years experience in a GMP facility.
– Knowledge and experience in process operations and associated control strategy of an oligonucleotide manufacturing process or like process.
– Knowledge of pharmaceutical manufacturing processes, quality improvements and efficiency.
– Ability to clearly and effectively write technical documents.
– Ability to work effectively as a team to accomplish deadlines and objectives, yet make independent decisions on various tasks.
– Knowledge of cGMP guidelines as well as international regulations pertaining to the production of APIs.
Our client is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.