Manager, Technical Investigations

Job Description

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines.

Technical Investigations Manager provides guidance and compliance expertise within the Manufacturing Operations and QC Investigators. The role is responsible for the following activities:

• Supervises activities, workload, and priorities for the investigations team
• Coordinates and supports investigation activities for gathering information from internal and external sources to determine root cause, evaluate product and equipment impact, evaluate risk to previous or future batches and develop effective CAPAs.
• Empower and assure comprehensive investigation reports
• Advise on, author and revise technical documentation including facility and equipment SOPs.
• Direct actions and content, or author and manage change controls and CAPAs.
• Participate in customer and regulatory meetings and audits/inspections
• Oversees, supports, and is responsible for presenting future development requirements or opportunities to the investigations team.

Essential Duties & Responsibilities:

Deviation Investigation and CAPA:

• Thoroughly investigate deviation events using root cause analysis techniques. Utilizes technical writing strategies to ensure content is clear, concise, and complete. Lead team to evaluate pertinent aspects involved in determining deviation scope, root cause and impact. Identify necessary CAPAs to address root cause and contributing causes discovered during investigation.

Change Control Management and Document Revisions:

• Write and manage change controls as necessary to implement changes to documentation and SOPs to facilitate improvements driven by the deviation, CAPA and compliance inspection systems.

Customer and Regulatory Support:

• Responsible for maintaining compliance and inspection readiness within the Operations department in the following ways:
• Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.
• Represent deviations, CAPA, and change controls during customer meetings and customer/regulatory inspections.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor's or Master's Degree or equivalent plus directly relevant experience
• Typically, a minimum of 1-2 years experience formally or informally leading people, projects and/or programs for entry to this level
• 5+ years of related professional experience preferred.
• Prior experience with people management is preferred.
• Prior experience and/or training working in a GMP manufacturing environment is helpful.
• Knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs and drug products.
• Knowledge and understanding of the oligonucleotide manufacturing or related pharmaceutical manufacturing processes preferred.
• Knowledge and experience with various root cause analysis methodology required.
• Skill in communication, written and verbal.
• Ability to lead cross-functional teams.
• Ability to collaborate with clients and regulatory agencies as required.

#LI-DT1

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity 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 diversity in the workplace 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 [email protected] or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Pay Range

$115,680.00-$180,750.00

The salary range for this position may differ based on your actual work location.

Eligible for Company Car

No

Benefits in Brief

Travel Required

Occasional

Schedule

Schedule:Full time

Shift

Day

Duration

No End Date

Job Function

Manufacturing