R&D Validation Engineer
- Posted: over a month ago
The incumbent will be responsible performing basic to moderate level engineering tasks to support the development of new and existing HCT/Ps, medical devices, cosmetics, and biologics as well as to support compliance of the Research and Development laboratory to FDA and ISO standards. Primary responsibilities will include coordinating and supporting activities for product development; to include design verifications, process validations, and stability studies; as well as to support the validation/qualification of laboratory computer systems (including analysis spreadsheets, instrument software systems, laboratory information management system (LIMS), electronic laboratory notebook (ELN) systems, inventory management, and other specialized software). Additional responsibilities include supporting the manufacturing of developmental products in a Good Manufacturing Practice (GMP) facility and to support clinical and laboratory tasks and other duties for the Product Development department following Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), where applicable.
Essential Duties & Responsibilities
- Responsible for conducting and completing tasks related to product and process development including, but not limited to:
- Generate and conduct the plan for assigned projects to include defining the objective, scope, time frame, budget, and procedures to accomplish the task.
- Evaluate feasibility of concepts to meet functional, clinical, and customer needs and provide input on the design, manufacturing process, quality needs, and testing during the development process.
- Design, optimize, and update processes and products utilizing lean concepts.
- Assist with defining, drafting, and performing product verification and validation activities (V&V).
- Coordinate and support stability study sample generation, pulls, and testing with internal and external personnel/vendors.
- Generate protocols, analyze data, and generate reports related to testing results.
- Collaborate in inter-departmental activities to ensure timely completion of project tasks.
- Responsible for conducting and completing tasks related to Computer System Validation including, but not limited to:
- Assist with identification and selection of systems through working with internal and external personnel/vendors to define user requirements, coordinate Part 11 compliance checklists, and draft supporting documentation including proposals and system feasibility for TissueTech, Inc. (TTI) needs.
- Assist with defining, drafting, and performing computer system V&V activities.
- Assist with performing risk assessments for existing and future computer systems.
- Responsible for supply and material coordination to support product development activities including, but not limited to:
- Qualification of new supply and vendors based on established SOPs/WIs.
- Purchase supply utilizing TTI’s enterprise resource planning (ERP) software.
- Receive, inspect, and release supplies based on established SOPs/WIs.
- Responsible for pilot scale manufacturing of developmental products including, but not limited to:
- Manufacturing in clean room environment to comply with GLP, GMP, and established SOPs/WIs.
- Request of supplies, raw materials, and placental tissues.
- Preparation of processing documents.
- Preparation of processing solution and storage solution.
- Set up and cleaning of processing area, equipment, and instruments.
- Processing, manufacturing, and packaging of products.
- Inspection of units processed, manufactured, and packaged.
- Request of labels and labeling of final products.
- Storage of final products.
- Complete legible documentation (e.g., processing forms, cleaning logs, etc.) for review.
- Follow established SOPs/Wis for activities conducted.
- Update or generate new procedures, as needed.
- Complete requisitions for quality control and other testing samples and submit to the designated testing facility.
- Document/report equipment and facility problems and any potential deviations during processing.
- Maintenance of records to comply with regulatory requirements and established SOPs/WIs.
- Maintain effective communication with supervisor and peers in project activities.
- Assist in post market evaluation/surveillance.
- Responsible for scientific technical writing including, but not limited to:
- Perform literature search using keywords using databases (e.g., PubMed).
- Retrieve relevant literature, compile, summarize, and write systemic reviews.
- Assist in manuscript and regulatory writing
- Backup for Research Associate, Lab Assistant, and Equipment Technician for tasks that are within capability.
- Bachelor of Science in Engineering (preferred), Biology, Chemistry, Biochemistry, or other technical discipline is required.
- Minimum 1 year of experience in Product Development, or related, is required.
- Minimum 1 year of experience in Computer System Validation, or related, is preferred.
Skills & Abilities
- Ability to multi-task, set priorities effectively, and to produce quality work in a fast-paced, regulated environment.
- Ability to follow verbal direction and to understand written policies, guidelines, specifications, and safety standards.
- Self-motivated, results-oriented, forward thinker that takes initiative to make things happen, accepts accountability, and work with minimal supervision.
- Proficiency in Microsoft software applications (i.e., Excel, Word, PowerPoint, and Outlook) is required.
- Proficiency in Statistical software applications (e.g., Minitab, SPSS, or similar) is preferred.
- Familiarity with Project Management Tools (e.g., Smartsheet) is preferred.
- Familiarity with relevant standards and methodologies (GAMP 5, ISO, FDA CFR, Risk Management)
- Excellent communication skills (oral/written).
- Up to 10% Domestic
Essential Physical Requirements
- Standing and walking: more than one-fourths of the workday.
- Sitting: more than three-fourths of the workday.
- Hearing: more than three-fourths of the workday.
- Vision: more than three-fourths of the workday.
- Communication, verbal: more than one-tenth of the workday
- Communication, written: more than one-fourth of the workday.
- Ability to lift up to 10 lbs.: up to one-tenth of the workday.
- Ability to lift up to 25 lbs.: seldom, up to one-tenth of the workday.
- Office environment.
- Laboratory facility with potential exposure to hazardous material.
- Cleanroom facility with potential exposure to hazardous material.
At TissueTech Inc., we offer competitive total rewards compensation. Our commitment to our employees includes benefit programs that are comprehensive, diverse, and designed to meet the various needs across our associate population. We take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions.
Our inclusive benefits include, but are not limited to:
Paid Time Off including vacation, floating holiday and paid bereavement.
Comprehensive health, vision, dental, HSA match, FSA and dependent care, STD, LTD, Life & AD&D Insurance, Supplemental insurance.
Prepaid Legal plan.
401k match - an investment in your future.
Exclusive employee discounts.
Company-wide events and outings.
COVID-19 Vaccination Requirement
TissueTech, Inc. requires its employees to be fully vaccinated against COVID-19 where allowable under the law, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents them from being vaccinated. If you are vaccinated, you are required to have received at least one COVID-19 shot prior to your first day of employment and to provide proof of your vaccination status.
Candidates who cannot perform one or more of these requirements due to disability will be eligible for consideration based on whether the candidate can perform the essential functions of the position with a reasonable accommodation.
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