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Analytical Instrumentation Manager

2 months ago

High Point, United States Cambrex Full time
Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today

Job Overview

Responsible for ensuring all laboratory instrumentation and associated software systems are in a state of regulatory compliance and readiness . Maintain system for tracking equipment on site, and coordinate with vendors or internal resources to perform maintenance, calibration, and repairs on all analytical laboratory equipment .

Responsibilities

 Write instrument calibration, qualification, and validation documentation compliant with site SOPs and cGMP.

Schedule and execute on-time IQ/OQ, calibration, routine maintenance, and re-calibration activities of pharmaceutical laboratory equipment in compliance with applicable SOPs m inimiz ing impact to laboratory activities and manufacturing. Proactively communicate timelines. Maintain strict timelines while demonstrating flexibility in day-to-day activities and scheduling. Update the calibration schedule and equipment lists as work is performed.

Provide advanced level expertise in responding to troubleshooting and repair requests to ensure uninterrupted operation of essential instrumentation. Demonstrate initiative in responding to situations as they arise and in accordance with all applicable SOPs.

Strong ability to effectively manage and organize multiple tasks & responsibilities with simultaneous competing priorities in a high-paced environment.

Set up standard and special purpose laboratory equipment to test, evaluate, and calibrate other instruments and test equipment.

Maintain inventory to ensure adequate parts and supplies are in stock. Complete requisitions for equipment and parts as needed.

Administer users and conduct standard configuration within instrument software.

Act as an escort for the approved vendors performing required external calibration and review calibration notebooks per applicable SOPs/procedures .

Manage laboratory equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.

Promote and provide excellent customer service and support. Maintain a positive relationship with all the members of CHP while promoting a positive team environment.

Comply with Good Manufacturing Practices (GMP) and follow company policies and safety regulations.

Supervisory responsibilities for Analytical Instrumentation Specialist including performance management.

Responsible for training new or existing analytical instrumentation team members.

Qualifications/Skills

Team Player with the ability to work collaboratively with colleagues from different departments for the good of the business overall.

Proven capability to focus on delivering excellent results.

Proven ability to recognize opportunities / issues and apply analytical and creative thinking to maximize performance.

Strong customer service focus and ability to effectively interact with all levels of employees.

Education, Experience & Licensing Requirements

 BA/BS in chemistry, life sciences, metrology, or related engineering or science discipline or equivalent (experience + education) plus minimum 9 years of experience in FDA-regulated pharmaceutical manufacturing industry, with minimum 5 years hands-on laboratory experience in equipment calibration/qualification.

Experience in Quality System/Pharmaceuticals, planning maintenance &/or calibration activities, and investigating OOT results is a plus.

Strong working knowledge of Agilent ChemStation/Open Lab, Waters Empower, and Nugenesis .

Strong knowledge of cGMP guidelines, FDA 21 CFR Part 11, 210/211, and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.

Strong knowledge and experience in the operation and qualification of pharmaceutical laboratory, facilities and manufacturing systems.

Demonstrated strong knowledge of metrology practices and theories and understanding of industrial instrumentation and measurement principals .

Good troubleshooting and problem-solving skills; ability to analyze and diagnose instrument failures rapidly and effectively .

Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential.

Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.

Ability to read/review design drawings with a basic understanding of P&ID, HVAC, & Electrical systems .

Understanding of technical documents such as URS, SAT, FAT, Validation Protocols .

S edentary work. The daily work is performed in an office setting as well as the laboratories. Walking and standing are required on a regular basis to interact with colleagues, vendors and work on equipment. Knowledge of working safely with chemicals required.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.

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