Computer System Quality Validation Engineer

SUMMARY: US WorldMeds is seeking a Computer System Validation Engineer to play a pivotal part in ensuring the compliance and efficiency of computerized systems involved in several stages of the Validation-cycle, from the upstream capturing the patient journey to the integration process as well as managing Quality Compliance of IT Systems relevant for GxP regulations. Proven end-to-end CSV experience, including planning, execution, documentation, and remediation. As a member of the Quality organization, an additional requirement is to provide Quality oversight on product, process, equipment, software, and facilities changes while ensuring the validation and qualification activities are consistent with regulations and USWM's validation practices and procedures. Familiarity with regulatory requirements around audit trails and access control is a plus.

DUTIES AND RESPONSIBILITIES:

The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

• Responsible for QA review and approval of all validation records and documentation (i.e. computer system validation and equipment lifecycle documentation including but not limited to URS, DQ, FAT, SAT, IQ, OQ, PQ protocols and reports).

• Participate in efforts to identify opportunities for and to implement continuous improvement and optimization of practices related to validation.

QUALIFICATIONS:

Required

• Bachelor's Degree in Science or related technical field.
• Minimum of 5 years of Quality Assurance/Validation experience working with automation and/or computerized system validations in the biotechnology or pharmaceutical industries.
• Must demonstrate understanding of cGMP's, industry and regulatory guidance, and multi-national biopharmaceutical/cell therapy regulations.
• Prior experience leading or managing projects beneficial
• Strong knowledge of global regulatory requirements for Clinical and Commercial GMP computerized systems validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, 21CFR210, 21CFR211, and 21CFR11.
• Knowledge of Quality Risk Management principles and experience with performing risk assessments using a variety of tools, i.e. FMEA.
• Must be able to work well on cross-functional teams, as well as perform independently. Strong organizational skills are required and must be able to prioritize multiple tasks.
• Must possess strong verbal/written communication skills and ability to influence at all levels.
• Experience utilizing quality systems to support CSV/CSA activities (Document management, Training, Deviation management, Change Control management, and CAPA).
• Proficient skills dealing with and understanding typical laboratory, facilities and manufacturing equipment for cell therapy manufacturing with single-use technologies, closed systems, and cold chain/cryogenic technologies.
• Deep knowledge of facility/clean room design, process, equipment, automation, and validation
• Ability to think strategically and to translate strategy into actions
• Must be able to prioritize multiple tasks and ensure completion in a timely manner while working within a fast-paced environment.
• Ability to provide clear direction to team members in a highly dynamic environment
• Candidate must be proficient in Microsoft Word, Excel, PowerPoint.

Desirable

• Experience with Calibration manager databases, Electronic Lab Notebooks, Veeva, Validation Data Acquisition systems (ie Kaye, Ellab, TempTale), Building Management systems, Document Control Software, Sepax/SepaxNet, Wave Bioreactors/Unicorn Software, MODA, Pas-X, StarLIMS.
• Experience with leading the start-up, validation, and licensure of manufacturing facilities.
• Strong knowledge and direct experience with systems and applications required for aseptic manufacturing.
• Experience working with cell and gene therapies or biologics products.

COMPETENCIES:

• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
• Computer Skills - Skilled with computers; Takes advantage of new technology; Learns new tools quickly; Uses technology to enhance job performance.
• Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
• Decision Making - Able to reach decisions; Takes thoughtful approach when considering options; Seeks input from others; Makes difficult decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
• Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
• Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
• Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS:

• Frequently required to stand
• Frequently required to walk.
• Frequently required to sit.
• Frequently required to talk or hear.
• Occasionally required to lift light weights (less than 25 pounds)
• Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus

WORK ENVIRONMENT:

• The noise level in the work environment usually is quiet.
• Aseptic Gowning is a requirement when executing validation work on the floor.