Manufacturing Operations Investigator
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Job Location:
Frederick, MD - USA
Monthly Salary:
$ 74560 - 116500
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Description
At Agilent we are driving innovation in life-changing lifesaving medicines. Join our team in advancing the next frontier of biopharma by supporting the production of nucleic acid therapeutics. We offer an opportunity to be part of a high-performance manufacturing team dedicated to delivering perfection in our new innovative facility. Together were helping craft the future of medicine.
The Manufacturing Operations Investigator position performs manufacturing investigations including but not limited to deviations environmental excursions nonconformances discrepancies etc. to improve the manufacturing process by implementing corrective and preventative actions. Other duties may include writing or revising SOPs Change Controls and other technical documentation generated by manufacturing.
Key Responsibilities
- Lead investigations activities by gathering information and data from all necessary internal and external sources using investigation tools to perform the following:
- root causes analysis (RCA)
- Evaluate the impact of deviation on the manufactured product and the equipment.
- Determine the risk to previous products or future operations.
- Collaborate with cross-functional teams to develop effective Corrective and Preventative Action (CAPA) plans to prevent recurrence.
- Author comprehensive investigation reports.
- Review quality and regulatory documents and conduct interviews with internal sources to obtain an in-depth understanding of the product and process.
- Analyze process data and evaluate trends to identify continuous process improvement opportunities.
- Consults with the Quality Assurance area subject matter experts and manufacturing groups to resolve quality production and efficiency issues.
- Manage multiple Non-Conformance Records (NCRs) CAPAs and Change Controls as necessary to closure within established timelines and batch disposition dates.
- Write and/or revises technical documentation including SOPs and other documents as needed.
Qualifications
- Bachelors degree in a science-related field or equivalent.
- Knowledge of Good Manufacturing Practice (GMP) guidelines as well as international regulations (i.e. International Conference on Harmonization (ICH) Q& pertaining to the production of Active Pharmaceutical Ingredients (API) and drug products.
- Possess the training and ability to lead investigations by applying scientific methods and effectively present findings and solutions to customers co-workers or members of management.
- Able to identify personnel and documentation to support knowledge of equipment and processes utilized to manufacture oligonucleotide APIs such as but not limited to Solid Phase Oligonucleotide Synthesis Deprotection Chromatographic Purification (AX RP HIC etc.) Ultrafiltration Concentration Annealing and Lyophilization.
- Skilled utilizing Microsoft products (Word Excel and Visio preferred).
- Skilled in managing various projects; must be able to use individual discretion in completing work assignments while assisting the group in establishing priorities setting standards and working collectively to accomplish deadlines and objectives.
- 3 years related experience and/or training working in a GMP Production Environment applying Root Cause Analysis techniques is required.
- Bachelors degree in a science-related field or equivalent experience.
1 years of meaningful experience ideally in a GMP manufacturing environment.
Strong understanding of GMP guidelines and international regulations for API and drug production.
Experience with root cause analysis technical writing and SOP development.
Proficient in Microsoft Word and other standard software applications.
Excellent communication and leadership skills with the ability to run cross-functional teams and sophisticated projects.
Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least January 19 2026 or until the job is no longer posted.The full-time equivalent pay range for this position is $74560.00 - $116500.00/yr plus eligibility for bonus stock and benefits. Our pay ranges are determined by role level and location. Within the range individual pay is determined by work location and additional factors including job-related skills experience and relevant education or training. During the hiring process a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: Technologies Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals regardless of personal characteristics are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex pregnancy race religion or religious creed color gender gender identity gender expression national origin ancestry physical or mental disability medical condition genetic information marital status registered domestic partner status age sexual orientation military or veteran status protected veteran status or any other basis protected by federal state local law ordinance or regulation and will not be discriminated against on these bases. Agilent Technologies Inc. is committed to creating and maintaining an inclusive in the workplace where everyone is welcome and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility please email or contact 1-. For more information about equal employment opportunity protections please visit Required: NoShift:
DayDuration:
No End DateJob Function:
Quality/Regulatory
Key Skills
- Epidemiology
- Public Health
- Bank Secrecy Act
- Bioinformatics
- Fraud
- Genetics
- Interviewing
- Law Enforcement
- Qualitative Research Interviewing
- Research Experience
- Next Generation Sequencing
- Writing Skills
