3 Senior Validation Engineer Jobs in Blue, OH
Aprecia Pharmaceuticals is Hiring a Senior Validation Engineer Near Blue, OH
| Duties/Responsibilities | |
| 1 | Work with cross-departmental teams to ensure the overall success of Validation & Qualification projects. |
| 2 | Provide Validation/Qualification guidance and support for the design and operation of Aprecia’s proprietary 3DP equipment across all platforms (Open Bed, In-Blister, and ZipCup Technologies). |
| 3 | Generation and execution of and/or technical review of various GMP documents. These documents include, but are not limited to, validation protocols, validation reports, user requirements, equipment specifications, deviations, and change controls. |
| 4 | Develop validation documentation including but not limited to: Commissioning / FAT (Factory Acceptance Test) / SAT (Site Acceptance Test), Qualification (IQ/OQ), Performance Tests, Summary Reports, Cleaning Validation, Computer System Validation, Engineering Studies, etc. |
| 5 | Perform risk analysis and assure appropriate parameters are evaluated with the required statistical approach to associated testing for justification and support of critical process parameters and quality attributes. |
| 6 | Assist process engineers for sampling and testing as needed for Validation protocols. |
| 7 | Generation and execution of re-verification protocols and/or periodic review activities to ensure critical equipment/systems are maintained in a validated state. |
| 9 | Ensure compliance with cGMP, regulatory requirements, validation standards, and quality systems for all validation activities. |
Reporting to this Position:No direct reportsTravel:Position may require up to 10% travel.Work Shift:This position works daysKnowledge, Skills and Abilities:
- Project management skills, strong oral and written communication skills
- Strong organization and relationship-building skills
- Ability to work independently or as part of a cross-functional team under deadlines and changing priorities
- Strong problem-solving, critical thinking, and math skills
- Ability to perform long-range planning in a team environment
- Willingness to work extended hours to complete job responsibilities
- Minimum B.A. degree in Engineering, Science, or related discipline and 5 years of experience in the pharmaceutical industry required.
- Excellent knowledge/proficiency of Microsoft Office and related computer programs required. Proficiency in Microsoft Project a plus.
- Working knowledge of the manufacturing, packaging, laboratory, and quality systems/processes needed to develop and produce OSD pharmaceutical products required.
- Proficient knowledge of cGMPs, including 21CFR Part 11, ALCOA , and Data Integrity principles.
- Working experience in cleaning validation, computer system validation preferred.
- Ability to sit for extended periods to perform job responsibilities at a desk or meeting table
- Good manual dexterity to operate computer, keyboard, and general office equipment
- Good eyesight to read technical/instructional materials and electronic communications
- Good hearing to address questions during presentations, to facilitate team discussion, etc.
- Occasional odd body positions (reaching, twisting, bending) in the performance of job duties
- Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (i.e. respirators, over-gowning, gloves, steel toe shoes)
Job Summary
Full Time
Pharmaceutical
$98k-114k (estimate)
12/09/2022
06/10/2024
aprecia.com
EAST WINDSOR, NJ
100 - 200
2004
Private
PAT ZAFARINO
$5M - $10M
Pharmaceutical
Related Companies
About Aprecia Pharmaceuticals
Aprecia Pharmaceuticals develops, manufactures and commercializes precision drug delivery systems and other related products.
The job skills required for Senior Validation Engineer include Project Management, Planning, Change Control, Microsoft Office, Validation Protocols, Packaging, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Validation Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Validation Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Senior Validation Engineer positions, which can be used as a reference in future career path planning. As a Senior Validation Engineer, it can be promoted into senior positions as a Validation Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Validation Engineer. You can explore the career advancement for a Senior Validation Engineer below and select your interested title to get hiring information.
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