Support validation of cGMP equipment, facilities and processes. These duties will include, but are not limited to: and validation of laboratory systems, production equipment, manufacturing processes and utilities.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Assist with maintaining and revising validation procedures.
- Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.
- Establish and execute programs covering equipment, processes, cleaning, process and computer system validation.
- Assure that all validation is performed to conform to GRAM’s and cGMP requirements.
- Provide validation support to internal customers such as Technical Services, Quality Control, Manufacturing and other users of validation services.
- Write, review and execute protocols.
- Write, review and execute studies for process improvement and scale up projects.
- Provide technical support to Manufacturing – troubleshooting and resolving process related issues.
- Identify process improvement opportunities and equipment needs for manufacturing/packaging.
- Develop and execute Deviations and CAPA based on validation changes.
- Review and approve forms associated with facility and equipment calibration, maintenance, etc.
- Maintains equipment logbooks and other forms to document proper cleaning and sterilization.
- Open to a flexible and fluid work environment. Work on any assignment as directed and flexibility to support limited multi-shift operations, training and testing.
- Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
- Support Agency, customer, and vendor audits as needed.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Perform all other tasks, projects, and duties as assigned.
SKILLS & ABILITIES
- Ability to interpret and relate Quality and Best Practice Qualification and Validation standards for implementation and review.
- Ability to meet scheduled timelines.
- Ability to work with a diverse customer base.
- Strong attention to detail; Ability to complete tasks with accuracy and efficiency.
- Portrays appropriate levels of integrity and professionalism.
- Excellent written and verbal skills; Ability to communicate effectively with management and staff by exhibiting excellent interpersonal skills.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results oriented and efficient; Acts with a sense of urgency.
- Creative and open-minded individual who fosters an environment in which sharing of ideas is encouraged.
- Ability to work well independently and in a cross-functional team environment.
- Must have proficient computer skills in Microsoft Word, Excel, and Outlook. Knowledge of GAMP5, ISPE Baseline Guides for Commissioning and Qualification and ASTME2500 preferred.
Qualified candidates have a Bachelors Degree in Engineering or a related field. A minimum of 0-3 years' related work experience in a pharm, biopharma, and/or biotech manufacturing environment preferred.