The Validation Engineer is responsible for supporting facilities and equipment qualification, as well as cleaning, process and packaging
validation programs, creation and execution of protocols and writing/routing/obtaining approval of final reports. The Validation Engineer is expected to work cooperatively across all functions to support launch of development products and processes. Includes technology transfer and scale up in an aseptic processing environment.
Essential Duties & Responsibilities
- Supports the installation and qualification activities for new equipment including, Installation Qualification
- (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
- Supports the integration of new technologies and new products.
- Ensures that all technical control is performed on all processes, processing equipment and systems within the
- Production Department.
- Assists the manufacturing associates in the Production Department in the technical processes to ensure its
- compliance with requirements established in GMP, FDA, GTPs, ISO and all other Regulatory bodies.
- Tests the equipment and ensure is ready to operate according to specification.
- Ensures the equipment is in compliance to GMP requirements.
- Assists in development and implementation of SOPs for the Production
- Performs risk assessments and develops process FMEAs for new and existing products.
- Performs data analysis, interpret results and develop actions based on those results.
- Bachelors Scientific field required
Minimum Years of Experience
- 3 years pharmaceutical Engineering required
Skills & Abilities
- General understanding of GMP, GTP, ISO systems; and documentation practices, aseptic technique, FDA and ISO regulations and successfully passed required training.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to analyze complex regulatory, clinical and quality issues and develop solutions that best meet the collective needs of the Company and regulatory agencies. Knows when to bring in outside expertise to address complex problems.
- Thorough understanding of GTP, cGMPs, quality systems and compliance requirements.
- Ability to represent TissueTech in inspections by national and international health authorities.
- Ability to communicate effectively both written and oral.
- Up to 10% Domestic Occasional travel to attend FATs and training.
Essential Physical Requirements
- Sitting frequent: from one-third to three-fourths of the workday
- Standing and walking occasional: from one-tenth to one-third of the workday
- Tasks – keyboarding, driving occasional: from one-tenth to one-third of the workday
- Reaching seldom: up to one-tenth of the workday
- Postural – crawling, crouching, stooping, kneeling seldom: up to one-tenth of the workday
- Up to 10 lbs. Seldom: up to one-tenth of the workday
Candidates who cannot perform one or more of these requirements due to disability will be eligible for consideration based on whether the candidate can perform the essential functions of the position with a reasonable accommodation.