Gahagan & Bryant Associates Inc
Senior Validation Project Lead/Manager
Gahagan & Bryant Associates Inc, Phila, Pennsylvania, United States, 19117
Position : Senior Validation Project Lead/Manager - Life Sciences Group
Location : Midwest US (Traveling)
Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry.
We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today's world, it's never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services. Compli is full services Commissioning, Qualification, Regulatory Compliance and On Demand services firm.
Supervisory Responsibilities : None Essential Functions :
Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects. Prepare and execute commissioning / validation lifecycle documents. Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade. Write summary reports for validation and qualification protocols. Support project milestones, priorities and deadlines. Write operating procedures for technical equipment and practices and procedures. Perform system and process risk assessments and analyses. Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management. Develop project specific validation plans and strategy. Able to manage and execute multiple projects to meet client's priorities. Provide a practical approach to problem solving. Individuals must represent COMPI at client sites and interact confidently with clients, contractors, management and peers. Other duties as assigned Education & Experience :
Bachelor's degree in a related life sciences or requisite industry training and experience. Must have minimum 7 years of CQV experience with aseptic liquid filling facilities, utilities, equipment, and systems. Technical Skills & Abilities :
Ability to converse about scientific matters. Ability to work independently or in collaboration with others. In depth understanding and application of validation principles, concepts, practices and standards. Considered a Subject Matter Expert (SME) in one area of validation. Proficient in current Good Manufacturing Practices and other applicable regulations. Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report. Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards. Excellent written communication skills with emphasis in technical writing. Proficient in Microsoft Word, Excel, Power Point and Project. Physical Requirements :
Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times. Travel :
Must be willing to travel regionally and/or nationally throughout the Eastern and Midwest US. Salary Range :
$120,000 to $150,000 per year.
It's more than just a job...
At Compli, we are about innovative and intelligent people who want to solve problems. We're known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology.
At Compli, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.
?
Location : Midwest US (Traveling)
Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry.
We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today's world, it's never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services. Compli is full services Commissioning, Qualification, Regulatory Compliance and On Demand services firm.
Supervisory Responsibilities : None Essential Functions :
Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects. Prepare and execute commissioning / validation lifecycle documents. Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade. Write summary reports for validation and qualification protocols. Support project milestones, priorities and deadlines. Write operating procedures for technical equipment and practices and procedures. Perform system and process risk assessments and analyses. Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management. Develop project specific validation plans and strategy. Able to manage and execute multiple projects to meet client's priorities. Provide a practical approach to problem solving. Individuals must represent COMPI at client sites and interact confidently with clients, contractors, management and peers. Other duties as assigned Education & Experience :
Bachelor's degree in a related life sciences or requisite industry training and experience. Must have minimum 7 years of CQV experience with aseptic liquid filling facilities, utilities, equipment, and systems. Technical Skills & Abilities :
Ability to converse about scientific matters. Ability to work independently or in collaboration with others. In depth understanding and application of validation principles, concepts, practices and standards. Considered a Subject Matter Expert (SME) in one area of validation. Proficient in current Good Manufacturing Practices and other applicable regulations. Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report. Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards. Excellent written communication skills with emphasis in technical writing. Proficient in Microsoft Word, Excel, Power Point and Project. Physical Requirements :
Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times. Travel :
Must be willing to travel regionally and/or nationally throughout the Eastern and Midwest US. Salary Range :
$120,000 to $150,000 per year.
It's more than just a job...
At Compli, we are about innovative and intelligent people who want to solve problems. We're known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology.
At Compli, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.
?