AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com

SUMMARY:

The Calibration Technician II - III is responsible for maintaining and improving the cGMP Calibration. This is a key position in the readiness of the instrumentation and equipment for new Bio-Manufacturing Facility as well as maintaining the current operation of the existing facilities.

PRINCIPAL RESPONSIBILITIES:

Perform calibration work on complex instruments such as Temperature, Pressure, Electronic, Flow, Weight, Level, Speed, pH & Conductivity, Laboratory Equipment and other manufacturing and utility system instrumentation.
Perform troubleshooting, installations and repairs of complex instrumentation on production, laboratory and facility systems, ensuring all systems and devices are calibrated in accordance with manufacturer's specifications and AGC Biologics internal SOP's.
Create, develop and update instrument work plan templates (WPTs). Establish, maximize and improve calibration process tolerances for site instrumentation while maintaining data integrity and measurement traceability for the Calibration Program.
Maintain assigned area of ownership within the facility to support inspection readiness and general facility upkeep for support of clinical and commercial manufacturing.
Complete calibration work orders and engineering change controls within the allotted time.
Maintain all calibration records, work orders, and investigations in an orderly and accurate manner in compliance with cGMP's by the utilization of the site CMMS and Document Management Systems.
Collaborate with manufacturing, quality and operations to understand issues, opportunities for improvements, and partner with them to drive optimization of programs.
Assist in qualification activities related to Instrumentation and Process improvement projects.
Assist with Off-site Calibration Activities, communicating with Vendors to get calibration quotes and purchase orders etc., and Interface with calibration contractors, ensuring work is compliant with AGC SOP's and cGMP's within the facility.
Assist in the development of investigations and initiation of any documentation resulting from 'Out of Tolerance' conditions with respect to instrumentation.
Provide training, coaching and technical direction to lower level Calibration Technicians.
Ensure compliance with all applicable regulatory agencies including FDA, OSHA, CFR, etc.
Plan sequence of testing and calibration procedures for instruments and equipment.
Assist in Regulatory and Internal Audits / Inspections.

KNOWLEDGE, SKILLS & ABILITIES:

Strong knowledge of calibration procedures and techniques, including calibration of Temperature, Pressure, Electronic, Flow, Weight, Level, Speed, pH & Conductivity, Laboratory Equipment among other manufacturing and utility system instrumentation such as: Autoclaves, CIP/SIP systems, Incubators, Analytical equipment, and Process tanks as well as other facility instruments. This will include equipment instrumentation and instruments installed in Loops.
Strong written, verbal and interpersonal communications skills.
Strong analytical and problem solving skills and experience applying these skills to resolve technical problems.
Strong skills and experience in MS Office products (Word, Excel, Outlook, PowerPoint).
Computer literate in Blue Mountain or similar computer based maintenance program desirable.
Demonstrated ability to works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations to management
Knowledgeable of Electrical, Mechanical, Control/SCADA, PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Biotechnology, Pharmaceutical, Medical Device Utilities Process.
In-depth knowledge of calibration and documentation requirements for cGMP manufacturing.
Demonstrated good interpersonal skills, customer focus, and professionalism.
Ability to read, interpret, and troubleshoot engineering drawings, P&IDs, and electrical schematics with assistance when needed.
Ability to work quickly and effectively without constant supervision.
Ability to work in different shifts if required.
Ability to work in a fast-paced environment.
Ability to work in prolonged sitting, standing, walking, bending, stooping and stretching.
Ability to climb ladders and stairs of various heights.
Ability to be exposed to noisy environments.
Ability to regularly lift and/or move up to 45 pounds and occasionally lift and/or move up to 70 pounds briefly.

EDUCATION/EXPERIENCE:

High School diploma or GED required.
Associate degree in Instrumentation or a related discipline with a minimum of 2 to 5+ years of overall experience in calibration activities of which at least 2 years should be in a cGMP or other FDA regulated operations for a Level II or at least 4 years for a Level III.
Strong written, verbal and interpersonal communications skills.
Strong analytical and problem solving skills and experience applying these skills to resolve technical problems.
Strong skills and experience in MS Office products (Word, Excel, Outlook, PowerPoint).
Ability to read, interpret, and troubleshoot engineering drawings, P&IDs, and electrical schematics with assistance when needed.

COMPENSATION RANGE

$28.73 - $49.55 per hour

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance.

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Apply for this Job

* Required

First Name *

Last Name *

Email *

Phone *

Location (City) *

Resume/CV *

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

Cover Letter

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

When autocomplete results are available use up and down arrows to review

+ Add another education

How did you hear about this position? *

If you are being referred to AGC Biologics by a current employee, please enter their name below.

What are your salary expectations? *

Current Mailing Address: *

Address, City and State

Are you willing to relocate? *

If you are able to relocate, do you have a preference between Bothell, WA, Boulder, CO or Longmont, CO?

Have you signed a non-competition or non-solicitation agreement with a former employer? If so, please provide the name of the employer and the date in which the non-competition and/or non-solicitation agreement expires. *

Have you ever been debarred, or are subject to a pending debarment, by the US Food and Drug Administration, or been or are listed by any federal and/or state agencies as excluded, debarred, suspended or otherwise been made ineligible to work in the drug or healthcare industry? *

AGC Biologics may conduct a pre-employment background check which may include criminal, employment, and financial. Is there anything that may prevent you from successfully passing this? Please answer "Yes' or 'No'. If you answered 'Yes', please explain. *

Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply. Will you require sponsorship to legally work in the US now or in the future? *

  I am a US citizen
  I require visa sponsorship
  I require visa transfer sponsorship
  I am a permanent green card holder

LinkedIn Profile URL

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in AGC Biologics ’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Are you Hispanic/Latino?

Please identify your race

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

Autism
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
Blind or low vision
Cancer
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or hard of hearing
Depression or anxiety
Diabetes
Epilepsy
Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
Intellectual disability
Missing limbs or partially missing limbs
Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

Disability Status

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.