Biospace Biological Science Job – Candidates Apply Online
The Andelyn Biosciences’ Manufacturing Science & Technology (MS&T) group is seeking a motivated individual to join our growing team as a Validation Sr. Specialist.
Biospace Biological Science Job, Prepare and execute equipment qualification plans and protocols. Write Final Summary Reports that summarize executed qualifications/validations. Assist in the development, coordination, and execution of qualifications/validation protocols for systems governed by regulations as applicable in the pharmaceutical industry. Coordinate validation related activities regarding equipment and processes being deployed in GMP environments
Job Title: Sr. Specialist – Validation – Manufacturing, Science & Technology (MS&T) – Plasmids Support
Location: Andelyn Corporate Center
1180 Arthur E. Adams Dr.
Columbus, OH 43221
Knowledge, Skills and Abilities required:
- B.S. Degree in Chemical / Biochemical / Biomedical Engineering, Biological Sciences or equivalent combination of bachelor’s degree and pertinent progressive experience in pharmaceuticals or other highly regulated industry
- Five years prior experience in validation, with knowledge of 21 CFR Part 210 and 211
- Experience in 21 CFR Part 11 desired
- Ability to communicate clearly with diverse group of team members
- Ability to drive project forward with collaboration
- Knowledge of Statistical software and calculations.
- Knowledge of analytical and process equipment, SCADA control system.
- Strong understanding of cGMPs and validation/qualification concepts.
- Ability to read, program, troubleshoot PLC Ladder Logic and HMI software.
- Ability to analyze pharmaceutical processes to determine critical parameters and critical quality attributes and design testing in the form of protocols to ensure robust and repeatable process. Must have in-depth knowledge of equipment set-up and operation, facility qualifications, master validation policies and protocol generation, and protocol execution.
- Ability to perform qualification and validation reporting.
- PC proficiency using Microsoft Office suite.
- Excellent written and verbal communication skills.
- Highly organized and detailed.
- Ability to read and comprehend written technical procedures, as-built drawings, P&IDs, blueprints as well as cGMP and SOPs.
- Ability to accurately perform mathematical calculations required by work assignments.
- Must be killed in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting
- Ability to work independently as well as collaboratively in a diverse and inclusive work environment
Minimum Physical Requirements
- Sitting Constantly
- Talking on the phone/in person Constantly
- Typing on a computer keyboard Constantly
- Moderate Standing/walking
- Ability to occasionally lift
- Ability to wear PPE on regular basis
- The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
- The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
- Specific vision abilities required by this job include close vision, and ability to adjust focus.
- Communicate using telephone and e-mail.
Under the guidance and direction of the Head of MS&T, essential functions of the Validation Sr. Specialist include at a minimum:
- Supports capital projects to establish new capabilities, or to modify/ improve existing capabilities. Applicant must be familiar with project delivery methodologies through the project lifecycle including charter, concept design, basic design, detail design, construction, commissioning, and qualification
- Supports the development of capital plans and improvements; engineering specifications and standards; and improvement of project delivery processes. In addition, the Project Manager provides business office support for the engineering department. This includes resource management, metrics, monthly reporting, and cost tracking/reporting
- Collaborates and coordinates with other functions such as Program Management, A&E service providers, Engineering, Validation, Maintenance, Manufacturing, Analytical/Process Development, and Quality Assurance. Represents projects to the user team, clients, and stakeholders
- Develop and execute equipment qualification protocols for all manufacturing, processing, and filling equipment and facilities/utilities supporting these operations.
Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.
- Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw material certificates of analysis.
Investigate and resolve deviations/exceptions from the predefined acceptance criteria.
- Draw conclusions from data, observations, deviation/exception and investigation as to whether process is considered valid.
- Review calibration/qualification records supplied by third party vendors.
Authors and reviews department SOP’s
Authors, Reviews and executes User/Functional Requirements Specifications (URS FDS),
- Risk Assessments (RA), Design Qualification (DQ), Qualification Test Protocols (IQ/OQ/PQ)
- Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.
- Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.
Ensure protocols, verifications, validation plans and summary reports generated during validation/ qualification activities are stored according to procedure.
- Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company. Work proactively to maintain the highest level of compliance in all areas. Gather current knowledge from QA/QC, regulatory, periodicals and/or appropriate training programs.
- Develop and execute cleaning validation/verification protocols for manufacturing and processing equipment.
- Perform proper and timely sampling of in-process/intermediate products, finished products, rinse water and surface swabbing for testing as outlined by validation/qualification protocols.
Perform physical testing from representative samples.
- Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA and QC to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.
- Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
- Perform other related duties as assigned to meet departmental and Company objectives.
- Moderate involvement in audits
- Moderate involvement in customer relations
- Other duties as assigned
Biospace Biological Science Job