Quality Engineer II

INTAKE NOTES:
- Onsite
-Extension possible
-What hours will the person be working 8hr First shift. Start time 7am-9am
MUST HAVE Validation experience and Quality experience.

ROLE BASICS

Job Title: Quality Engineering 2

Job Level / Seniority: 2

Number of Positions Needed:1

What would immediately turn you off from a candidate upon resume review

No relevant experience. (equipment is only freezers fridge and chambers)

Has never authored a validation

Has never authored risk assessments ( pFMEA NCE experience)

LOCATION & WORK MODEL

Primary Work Location (full address):10210 Genetic Center Dr San Diego CA 92121

Work Mode (Onsite / Hybrid / Remote): Onsite

TIMING & DURATION

Target Start Date: As soon as possible ( mid June)

Is timeline flexible If yes explain: /- a week

Expected Assignment Duration: 6 months

Extension Possible (Y/N):Y

Conversion Possible (Y/N):N

BUSINESS CONTEXT

Success criteria for first 90 days (what success looks like):

QE should be able to be independent after training for 3-6 weeks.

TEAM & ENVIRONMENT

Team size: team of 8-10

Reporting structure / key stakeholders: Reporting to Brenda Koka

Primary people this role works with: cross functional role with other quality and operations/Mfg teams.

SCHEDULE & EXPECTATIONS

Typical schedule:8-4 or 9-5

Shift start time: flexible. Must be in by 9:30

Shift end time: flexible (dependent ton time in)

Overtime expected (Y/N):N

Weekend work expected (Y/N):N

Travel required (Y/N % if yes):N

PHYSICAL / SITE REQUIREMENTS

Dress code: casual closed toe shoes for lab

PPE required (if any): For lab support (lab coat booties safety glasses)

Badging/access requirements: Yes

Parking or site notes: on site no assignment

SKILLS & EXPERIENCE

Top 3 required skills (ranked):

1. Authoring Validation and strategies

2. Review of change control ( good GMP knowledge)

3. detail oriented

Required certifications or training: n.a

EXPERIENCE GUARDRAILS

Desired years of experience: min 3yrs

Underqualified below: less than 2

Overqualified above: n/a

SOFT SKILLS & WORK STYLE

Important soft skills: communication with cross functional teams and escalation with management

Preferred work style (independent team based fast paced etc.): fast paced independent work.

INTERVIEW PROCESS

Number of interview rounds:1

Interview format (phone/video/onsite): video

Open to single round interview for non senior roles (Y/N): N

Expected resume review & feedback turnaround (e.g. 24 48 hours):48hours

Skillset Matrix Manager Notes
Technology Requirements (I.E Programs systems etc) MS Word Excel Project
What does a typical day look like (daily tasks) Quality Reviews and assessment of Non conformances Change orders. Review and approve development studies. Attend project meetings and draft Validation protocols & reports assist in execution.
Preferred background/prior work experience Validation experience in custom equipment. Design validation protocols and statistical sampling.
Risk assessment in FMEA format
Priority soft skills Good at problem solving.
Working cross functionally with other departments.
Organized- able to manage multiple projects and tasks
Communication- keeping every department in the project aware of the project needs.


Job Summary
The Quality Engineer II is responsible for validation of analytical methods cleaning production process equipment qualification facilities/utilities qualification and raw materials qualification. Additionally generate and maintain process FMEA for production processes perform risk assessments for process related non-conformances and planned deviations provide support and content for regulatory submissions write master validation plans protocols and reports support equipment and facilities change controls and perform validation impact assessment for change orders.

Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Provides Quality leadership to new product development teams in the areas of validation design transfer risk management and specification development.
Author master validation plans and reports.
Author and execute validation protocols and reports (Analytical Methods Equipment Facilities/Utilities Raw Materials Process and Cleaning).
Review the quality validation impact and completeness of document change order requests and change controls (Equipment or Facilities).
Determine validation strategy based on acceptable risk-based approach.
Lead cross-functional team to write PFMEAs under limited supervision.
Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV).
Assist in maintaining validation records.
Support cross-functional teams during New Product Introduction (NPI) and Sustaining projects.
Review regulatory submissions and/or notifications under limited supervision.
Propose improvement projects with supporting data flowcharts etc.
Assist in developing/updating departmental procedures and other controlled documents.
Evaluate adequacy of specifications for new or modified process designs under limited supervision.
Lead department and cross-department projects under limited supervision. Determine QE deliverables and assist in generating project timelines.
Participate in process design reviews.
Assist QE management in Material Review Board (MRB) and Production Response Team (PRT) meetings.
Participate in department process improvements goal(s).
Assist in development maintenance and reporting of department metrics.
Provides management with status updates on assigned responsibilities goals and escalate issues in a timely fashion.

Physical Demands
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Sit; use hands to finger handle or feel objects tools or controls.
Stand; walk; reach with hands and arms; and stoop kneel crouch or crawl.
Lifting/moving and carrying products weighing up to 40 pounds.
Exposure to moving mechanical parts vibration and/or moderate noise levels.
Exposure to hazardous chemicals or other materials.
Exposure to blood.


Qualifications
Education
Bachelors degree in Science or Engineering.

Experience
0-2 years of experience in a diagnostic medical device biotech or pharmaceutical company.

Skills
Proficient in validation methods and evaluation criteria.
Experience with process validation analytical method validation cleaning validation facility/utility and equipment qualifications.
Experience with change control process and documentation requirements.
Experience with electronic document management systems.
Understanding of statistics SPC and acceptance sampling.
Experience with risk analysis and PFMEA.
Working knowledge of CDRH CBER and ISO regulations (e.g. 21 CFR Part 820 ISO 13485 ISO 14971).
Working knowledge of 21 CFR Part 11.