- Generate and execute, with the support of key stakeholders, validation protocols, qualification protocols, and summary reports inclusive of cleaning validation, process validation, computer systems validation, design qualification, installation qualification, operational qualification, and performance qualification as appropriate.
- Perform quality engineering reviews of design documentation for compliance with stated requirements including vendor quality manuals and company quality records.
- Ensure all validation activities are up to date in accordance with Good Validation Practices and cGMP.
- Review maintenance requests and work orders to assess impact of work to existing qualified state.
- Support key internal stakeholders on review of new equipment, process, and system requests and assess for validation requirements.
- Participate in customer audits and regulatory inspections.
- Author, review, and/or approve SOPs and policies related to validation processes and equipment.
- Draft Confirmation of Changes for appropriate equipment, systems, and processes within guidelines of cGMP and GAMP
- Maintain compliance with cGMP and all competent authority guidelines by regularly reviewing and adhering to SOPs.
- Adhere to set safety standards.
- Bachelor's Degree and 5+ years of relevant experience OR Associate Degree and 10+ years of relevant experience.
- Thorough knowledge of and proven experience in validation role within the clinical, pharmaceutical, or R&D environment.
- Cleaning validation experience strongly preferred.
- Demonstrated ability to work independently, handle multiple tasks simultaneously, and meet internal and external customer timelines.
- Ability to work in a cross-functional / matrix environment.
- Strong oral and written communication skills.
- Ability to follow and interpret cGMPs, FDA, DEA, OSHA and ISO regulations and guidelines.
- Working knowledge of personal computers and Microsoft Office Products, including Word, Project, and Excel.
-
Validation Engineer
6 days ago
Sharp Clinical Services Bethlehem, United StatesDrafting and executing Validation and Qualification Protocols related to cleaning, equipment, computers, process and facilities as well as drafting Summary Reports for executed protocols at the direction of the Manager, Validation Engineering. Second Validation Engineer, Validati ...
-
Validation Engineer
2 weeks ago
Sharp Corporation Bethlehem, United StatesSummary · Responsibilities include drafting and executing Validation and Qualification Protocols related to cleaning, equipment, computers, process and facilities as well as drafting Summary Reports for executed protocols at the direction of the Manager, Validation Engineering. ...
-
Validation Engineer
2 weeks ago
Infinity Systems Slatedale, United StatesConnecting people and technologies, creating the perfect match for our clients, and always finding the right experts for each challenge - that is our goal at FERCHAU and that's why we are looking for you: as an ambitious colleague who, like us, wants to take technologies to the n ...
-
Validation Engineer
10 hours ago
Validation & Engineering Group Inc. Allentown, United StatesValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Valid ...
-
Validation Engineer
3 days ago
Merck & Co., Inc. Lansdale, United StatesQualifications: · Associate's degree or higher preferred with 1-2 years of experience or 4-5 years working experience in metrology/information technology / customer service or other relevant field. Experience working in a GMP environment and maintaining laboratory equipment. High ...
-
Validation Engineer
3 days ago
Collabera Lansdale, United StatesHome · Search Jobs · Job Description · Validation Engineer · Contract: West Point, Pennsylvania, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 20 hours left · Apply · Qualifications: · • Associate's degree or higher preferred with 1-2 years of experi ...
-
Validation Engineer
2 weeks ago
Collabera Lansdale, United StatesHome · Search Jobs · Job Description · Validation Engineer · Contract: West Point, Pennsylvania, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 13 days, 3 hours left · Apply · Qualifications: · •Associate's degree or higher preferred with 1-2 years of ...
-
Validation Engineer
1 week ago
Collabera Lansdale, United StatesHome · Search Jobs · Job Description · Validation Engineer · Contract: West Point, Pennsylvania, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 4 days, 3 hours left · Apply · Qualifications: · • Associate's degree or higher preferred with 1-2 years of ...
-
Validation Engineer
1 week ago
Integrated Resources Lansdale, United StatesJob ***** Validation Engineer - I · Location : West Point, PA 19486 · Duration : 6 Months Contract · Pay ***** $35/hr. on W2. · Job ***** · Review, and archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installatio ...
-
Validation Engineer
2 days ago
Merck & Co. , Inc. Lansdale, United StatesQualifications: · Associates degree or higher preferred with 1-2 years of experience or 4-5 years working experience in metrology/information technology / customer service or other relevant field. Experience working in a GMP environment and maintaining laboratory equipment. High ...
-
LL-01-061124 - Validation Engineer
2 days ago
Validation & Engineering Group Allentown, United StatesJob Description · Job DescriptionValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engin ...
-
Process Validation Engineer
3 weeks ago
QuVa Pharma Bloomsbury, United StatesOur Process Validation Engineer plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include providing hands on support in the development and execution of products, prog ...
-
Validation Engineer
2 weeks ago
Innova Solutions Lansdale, United StatesJob ID: · Lansdale , · Pennsylvania · Job Type: · Contract · Added - 05/09/24 · Job Description · Innova Solutions is immediately hiring for a · Validation Engineer - I · Position: Type: Full Time, Contract · Duration: 06 Months Contract · Location: · West Point, PA 1948 ...
-
Validation Engineer
3 weeks ago
Collabera LLC West Point, United StatesQualifications: · Associate s degree or higher preferred with 1-2 years of experience or 4-5 years working experience in metrology/information technology / customer service or other relevant field. · Experience working in a GMP environment and maintaining laboratory equipment. · ...
-
Validation Engineer
3 weeks ago
Integrated Resources Lansdale, United StatesJob Title: Validation Engineer - I · Location : West Point, PA 19486 · Duration : 6 Months Contract · Pay Rate: $35/hr. on W2. · Job Description: · Review, and archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Insta ...
-
Validation Engineer
3 weeks ago
Innova Solutions Lansdale, United StatesJob Description: · •Review, and archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification documentation, and calibration documentation. · •Verify equipment asset information in multiple lo ...
-
Assistant Validation Engineer
3 weeks ago
Compu-Vision Consulting, Inc. West Point, United StatesPosition: Validation Engineer - I (Assistant) · Location: West Point, PA · Job Description: · Review, and archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification documentation, and calibr ...
-
Senior Quality Engineer
3 days ago
TES Recruiting Solutions Bethlehem, United StatesQuality Engineer · Location: Bethlehem, PA · Relocation Package: Available · Job Summary: · As a Global Quality Assurance Engineer, you will spearhead quality assurance efforts, ensuring product and process excellence across our manufacturing sites. This role involves conduct ...
-
UIG - Quality Assurance Supervisor
3 weeks ago
Universal Industrial Gases, LLC Bethlehem, United StatesJob Details · Division: Universal Industrial Gases, LLC · Location: Bethlehem, PA, United States · Other Available Locations: Arkansas; Kentucky; South Carolina; West Virginia · Basic Job Functions: · Universal Industrial Gases, LLC. (UIG) is a wholly owned subsidiary of Nu ...
-
Trailer Technician
3 weeks ago
Western Express Bethlehem, United StatesIt's fun to work in a company where people truly BELIEVE in what they're doing If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us · Western offers competitive pay, benefits, paid time off, paid holidays, and a family-ori ...
Validation Engineer - Bethlehem, United States - Sharp Corporation
Description
SummaryResponsibilities include drafting and executing Validation and Qualification Protocols related to cleaning, equipment, computers, process and facilities as well as drafting Summary Reports for executed protocols at the direction of the Manager, Validation Engineering. Secondary responsibilities include drafting Validation Qualification Protocol Events encountered during protocol execution. Responsible for ongoing contact with Packaging Engineering, Operations, Quality Assurance, Project Management, and customers regarding validation activities and scheduling. The duties of this position directly impact company compliance to regulatory requirements and customer satisfaction.
Essential Duties and Responsibilities
The following is a list of minimum responsibilities related to this position. Other duties may be assigned.
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to handle or write to speak and hear. The employee frequently is required to sit. The employee is regularly required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
Environmental Conditions
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. While performing the duties of this job, the employee is normally required to sit at a desk and frequently go onto the shop floor and to work in close proximity to packaging equipment. The working environment is clean and not normally subject to hazardous environment or conditions.
This position is afforded the benefit of working in a hybrid arrangement. This role must have an on-site presence, averaging at least three (3) days on site on a weekly basis. Business needs may require this position to be onsite more than three (3) days per week with or without notice. Working remotely must be done in a dedicated, quiet workspace with minimal distractions and/or interruptions.
