About this position:
The Validation Manager will be involved in validation projects at Armata’s existing and new cGMP facilities in Marina del Rey, CA, for biological products manufacturing. This is a superb opportunity for candidates considering a validation management career in biotechnology or the life sciences.
Ethical conduct and compliance
Ensures compliance of self and others to internal and external procedures/regulations.
Fiscal and financial control
Follows financial policies, manages people resources to policy requirements and delivers budgets.
Optimizes performance outcomes of direct reports and ensures individuals understand the contribution they make.
Leadership and engagement
Understands the big picture and connects individuals to it in a meaningful way.
Is accountable for ensuring compliance is understood and maintained across own functional area. Ensures that the required initial and continuing training of the department personnel and organization is carried out and adapted per need.
Job description and technical requirements:
- Develops and directs intermediate and finished product qualification and validation program encompassing facilities, utilities, aseptic processing, equipment, automated controls/ computer systems, process/product, cleaning, and shipping.
- Write and review qualification and validation documents (Master Plan, SOPs, URS, DQ, IQ, OQ, PQ, and PPQ/PV, etc. in compliance with corporate standards, good scientific and statistical concepts, and regulatory requirements.
- Coordinate qualification and validation trials and testing.
- Coordinate, prepare, review and/or approve comprehensive reports compliant with cGMP regulations and Good Documentation Practices. Review validation packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis.
- Compare results against acceptance criteria and work to resolve exceptions and deviations.
- Performs and oversees criticality and risk assessments of processes, equipment, and instruments and ensures that operating and calibration ranges and tolerances are appropriate for processes being validated.
- Partners with development and quality organizations to evaluate products and processes, including prior development, analytical, and manufacturing data, to ensure critical/key process parameters, operating targets and ranges, and controls are defined, justified and documented.
- Actively participates during all phases of validation; plans, documents and executes validation activities, and leads validation team, including consultants and contractors if applicable, and supervises executions.
- Participates in the generation and/or update of validation master plans and reports status to management.
- Participates as applicable in product and process trend reviews and annual product reviews to ensure processes remain in controlled validated state.
- Manages master validation system which tracks all required qualifications and validations, including periodic revalidations or validation associated with changes in equipment, processes, materials, or controls.
- Ensures all qualification and validation activities comply with applicable Change Control procedures and product applications. Responsible for Validation department evaluation and approval of equipment and process change controls to ensure compliance to company standards, procedures, and applicable regulatory requirements.
- Oversees or performs investigations of failures, non-conformances, or deviations from protocol, standard operating procedure, or process requirements, and assesses impact upon qualification or validation status. Ensures all issues, deviations and non-conformances are resolved prior to report approval.
- Ensures test methods supporting qualification or validations are scientifically sound, formally documented, and validated or compendial, as applicable.
- Work with Quality Unit to ensure that product is not released to commercial distribution until all validation requirements have been met and reports approved.
- Initiate and enforce necessary improvements and corrections; oversee contractors conducting validation.
- Establish priorities and schedule activities to ensure timelines and milestones are met.
Qualifications and Experience:
- BS or MS in Science or Engineering discipline
- Minimum 10 years’ experience in biotech/pharma Validation projects or equivalent combination of education and experience.
- Extensive experience (minimum 5 years) in validation design, performance, data analysis, and document preparation, including sterile aseptic processing, autoclave equipment, and sterile Water For Injection (WFI) systems.
- High level of integrity and desire to comply with regulations and corporate standards.
- Knowledge of EU/international and US cGMP regulations for pharmaceutical guidelines, manufacturing operations, metrology requirements, validation procedures and practices.
- Excellent verbal and written communication, interpersonal and communication skills.
- Exhibits sound judgment by evaluating problems thoroughly, soliciting input and ideas, and reaching appropriate conclusions, assessments, and corrective actions where applicable.
- Appropriately challenges the status quo and uses knowledge and experience to continuously improve work processes.
- Experience supervising others and managing a department.
- Experience in a pharmaceutical or FDA regulated company required.
- Experience in pharma and/or biotech cGMP aseptic manufacturing equipment and procedures.
- Good working knowledge of use of statistics in calibrations and validation.
- Experience in failure mode analysis, statistical and risk assessment tools.
Physical Working Conditions:
This is a full– time position for work in a laboratory environment. The position requires wearing personal protective equipment. Occasionally, may require lifting or moving equipment up to 20 pounds and may require standing for extended durations throughout the day. Upon request, reasonable accommodations will be offered to enable individuals with disabilities to perform essential functions. There is little to no travel required of this position, with the exception of required training and possible conference or event attendance.
About Armata Pharmaceuticals, Inc.:
Armata is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.
Pay: $120,000 – $150,000 per year
Send cover letter and CV to: firstname.lastname@example.org