The Senior Validation Engineer will oversee validation activities at the new sterile fill-finish facility located in Dallas, TX. The Senior Validation Engineer will oversee and manage the CQV program and start up activities for the new sterile manufacturing site as it related to the manufacturing, facility, and utility equipment and processes. Previous sterile fill-finish experience is essential for this role.
DUTIES, RESPONSIBILITIES AND FUNCTIONS:
- Oversee and manage the CQV program for the new sterile manufacturing site as it related to the manufacturing, facility, and utility equipment.
- Support the development and execution of the IQ, OQ, and PQ protocols and summary reports for of the sterile manufacturing, facility, and utility equipment.
- Manage the workload and track progress for any onsite external CQV consultants and contractors.
- Write and implement validation activities for Facilities, Equipment, Shipping / Cold Chain, Process, Cleaning, Steaming / Autoclave, Computer systems, Plant Automation, Validation Maintenance and Validation document control and archival program.
- Develop, assess, and collaborate with the Quality Unit any quality related system elements specific to validation including but not limited to Quality Risk Management program, CAPA's, Change Controls, Deviations and GMP Investigations.
- Lead the cleaning and process validation efforts.
- Calculation and interpretation of data for Equipment Validation Studies.
- Develop, review and modify Standard Operating Procedures (SOPs).
- Execution of Test Protocols including identification and resolution of nonconformances/deviations.
- Tracking and managing change control activities for multiple concurrent projects.
- Maintain a “Never willing to compromise on Quality” attitude.
- Bachelor’s Degree in Engineering or Life Sciences with 10+ years of relevant work experience including 8+ years of experience in the Pharmaceutical or Biotech industry
- Master’s Degree in Engineering or Life Sciences with 8+ years of relevant work experience including 6+ years of experience in the Pharmaceutical or biotech industry.
TRAINING & BASIC QUALIFICATIONS:
- Extensive knowledge of cGMP, 21CFR, Part 11, GAMP, GDP requirements and FDA regulations
- Aseptic gowning experience and training required
- Direct experience with regulated environments (i.e., cGMP, OSHA, EPA).
- General understanding of Quality Systems
- Working knowledge of pharmaceutical/biotech processes
- Computer-savvy with SAP experience preferred
- Project Management experience required; PM certification preferred
- QMS experience and training preferred
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio
- Minimum 8 to 12 years of experience working directly in the Pharmaceutical or Biotech industry
- At least 4 to 6 years of experience in a sterile manufacturing (Drug Product Ops) validation engineering role
- Greenfield/Brownfield site or facility expansion construction and startup experience strongly preferred
- Experience interacting with FDA during inspection and audit
- Facility startup and CQV experience strongly preferred
- Sterile fill finish manufacturing and/or Drug Product Ops experience (required)
- Demonstrated a working knowledge of pharmaceutical manufacturing equipment as well as facility and clean utilities equipment, aseptic processing, and process development & scale up
- Automation, PLC controls & instrumentation experience preferred
- Ability to read/interpret engineering drawings, design documents, P&IDs, PFDs, and System boundary drawings
- In-depth understanding of scientific and engineering principles
- Experience in statistical analysis
- Knowledge of data management tools and statistical process controls
- Process validation experience and supporting regulatory filings and inspections
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills
- Excellent interpersonal, verbal, and written communication skills
- Ability to function efficiently and independently in a fast-paced, changing environment
- Self-motivated and willing to accept temporary responsibilities outside of the job description