Manufacturing Operations Investigator

Agilent Technologies•Frederick, CO

About The Position

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, we're 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 SOP's, Change Controls, and other technical documentation generated by manufacturing.

Requirements

Bachelor's 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 API's 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.
Bachelor's 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.

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 (NCR's), CAPA's, and Change Controls as necessary to closure within established timelines and batch disposition dates.
Write and/or revises technical documentation including SOP's, and other documents as needed.