IGIV-C Technician I/II/III - Clayton, United States - Grifols SA

Description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world.

We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

SHIFT:
12 Hour Rotating Shift


Summary:

The IGIV-C Technician is responsible for the isolation of IgG by processing plasma intermediate paste and performing fundamental tasks within a GMP environment by cleaning and maintaining the workplace, cleaning, assembling and disassembling operating equipment per applicable procedures, assisting with process control manipulations and maintaining records/logs in accordance with current standard procedures.

TECH I:

Primary Responsibilities:

• Performs general housekeeping in compliance with the high standards required of a pharmaceutical operation.
• Assists in the preparation of all solutions required for the process area and dispenses necessary cleaning/sanitization reagents to clean and sanitize production areas and equipment.
• Demonstrates the care and safety necessary to properly safeguard facilities, equipment, product and co-workers.
• Assembles and disassembles production equipment.
• Operates production equipment (i.e. filters, vessels, skids, columns, etc.).
• Operates fork truck in a safe and efficient manner.
• Operates CIP circuits.
• Monitors and controls processes utilizing the DCS.
• Performs real time documentation during production run and maintains accurate records/logs.
• Performs integrity tests on Sterile Filters.

Additional Responsibilities:

Buffer Prep Activities:
Prepare filter aid for dispensing to zone 1, prepare and install filters, set up transfer panels and filters, assist in unloading of bulk chemical delivery tankers utilizing the DCS; initiate chemical loop circulation, monitor the state of solutions


Zone 1 Activities:
Receive and stage II+III paste, calibrate tank pH probes, prepare equipment and harvest filter cake.


Zone 2 Sterile Processing Activities:

Prepare and test sterile filters, oscillate and sample sterile bulks, assist in the preparation of initial sterile bulks, deliver bulks and sterilize the bulk tank to sterile filter connection.

Zone 2 Purification Processing Activities:

Assist in the regenerate, testing and packing of columns, assist in cleaning and testing U/F systems, utilize DCS and Unicorn control systems, assist in formulation of sterile bulks, calibrate tank pH and conductivity probes, prepares and installs filters for use, sample and test process solutions.

Knowledge, Skills & Abilities:

Basic math skills, basic computer skills, mechanical aptitude, detail oriented, ability to work in a team environment and exercise good judgment.

Requirements:

• High School diploma OR GED required
• One year of regulated industry (FDA, USDA, NRC) experience OR Graduation from an accredited college/university with an Associate's or Bachelor's degree OR Completion of the Bioworks Certification Program preferred

Education

Requirements:
High school diploma or equivalent required. Candidate must possess a high school diploma or equivalent plus Bioworks Certificate or a high school diploma plus 1 year production manufacturing experience in a regulated industry (i.e. FDA, USDA, NRC) within the past 5 years or a 2 or 4 year college degree.


TECH II:

Primary Responsibilities:

• Performs all duties described at IGIV-C Technician level.
• Performs GMP and Safety Audits of Process area.
• Prepares and operates production equipment to standards (i.e. filters, column, bulk tanks, etc.) .
• Troubleshoots and identifies problems with production processes and equipment.

Additional Responsibilities:

Buffer Prep:

Prepare all buffer solutions and prepare and install filters, set up transfer panels for transfer to staging tanks, unload bulk chemical delivery tankers utilizing the DCS, sample and perform tests to determine acceptability of prepared solutions, initiate chemical loop circulation and monitor solutions.

Zone 1:
Stage and add II & III paste and calibrate tank pH probes.


Zone 2 Sterile Processing:
Prepare initial sterile bulks, oscillate, sample and sterilize bulks


Column Processing:
Assist in loading, performing evaluation testing and packing IGIV-C chromatography column


UF/DF Processing:

Clean and perform evaluation testing of system, monitor and control chromatography and UF/DF process, assist in initial sterile bulk formulation, sample and test solutions, calibrate tank pH and conductivity probes, prepare and install filters and install UF cassette in UF skid.

Knowledge, Skills & Abilities:

Basic math skills, basic computer skills, mechanical aptitude, detail oriented, ability to work in a team environment and exercise good judgment.

Requirements:

• High School diploma OR GED required
• One year of regulated industry (FDA, USDA, NRC) experience OR Graduation from an accredited college/university with an Associate's or Bachelor's degree OR Completion of the Bioworks Certification Program preferred

Education

Requirements:

Typically requires a minimum of 12 months as a Technician in his/her respective department before receiving consideration for advancement to IGIV-C Tech II.

Employee must receive a minimum of a meets expectations overall rating on his/her most recent performance review.

Employee must have demonstrated competence to perform independently in at least one of the Process Areas listed above and also be proficient in at least 2 of the Process Areas listed above prior to being considered for advancement to IGIV-C Technician II.

TECH III:

Primary Responsibilities:

• Performs all duties as described at IGIV-C Technician II level.
• Demonstrates the competence to perform process operations with minimal supervision.
• Demonstrate a thorough knowledge, understanding, and application of GMP, GLP, safety and housekeeping requirements.
• Assists in maintaining communication and cooperating with other teams to aid in constructive approaches toward departmental problems and/or process or equipment changes.
• Assists supervisors in establishing, implementing, and maintaining procedures for personnel safety, product integrity, security, and GMP/GLP.
• Assists supervisors in the development, improvement, and revision of written procedures (BPR's and SOP's)
• Assists in the training of less experienced personnel.; Assist in the write and update Job Safety Analysis (JSA); Successfully complete knowledge assessments; Other duties as assigned by the supervisor.
• Troubleshoots and identifies problems with the production process and equipment operation.
• Provides feedback for process improvements related to procedures.

Additional Responsibilities:

Buffer Prep:
Monitor buffer usage in process areas and plan buffer makeup as processing defines.


Zone 1:
Monitor processing for the Zone 1 operations for consistency.


Zone 2 Sterile Processing:
Independently set up, prepare and operate Zone 2 equipment (includes initial sterile bulk, sterile filter initial and sterile filling bulks)


Column Processing:
Independently load and pack the chromatography columns and perform HETP


UF/DF Processing:
Monitor and control the chromatography process utilizing the DCS control systems, monitor and control the UF/DF process utilizing the DCS and formulation of initial sterile bulks


Knowledge, Skills & Abilities:
Math skills, computer skills, mechanical aptitude, detail oriented, ability to work in a team environment and independently and exercise good judgment



Requirements:

• High School diploma OR GED required
• One year of regulated industry (FDA, USDA, NRC) experience OR Graduation from an accredited college/university with an Associate's or Bachelor's degree OR Completion of the Bioworks Certification Program preferred

Experience

Requirements:

Typically requires a minimum of 12 months as a Technician II in his/her respective department before receiving consideration for advancement to IGIV-C Tech II.

Employee must receive a minimum of a meets expectations overall rating on his/her most recent performance review.

Employee must have demonstrated competence to perform independently in at least two of the Process Areas listed above and also be proficient in at least 3 of the Process Areas listed above prior to being considered for advancement to IGIV-C Technician I.

Occupational Demands:

Must be able to lift up to 50 lbs, as well as stand/walk continuously during the shift, and work rotating shifts.

Required vaccination for hepatitis B due to exposure to plasma fractions

Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment and moving machinery. Exposure to high levels of noise and to dust/gas/fumes/steam. Exposure to extreme cold below 32*. Occasional entry into confined spaces, requiring kneeling, crawling, climbing and squatting. Works at heights on scaffolding and/or on ladders.

Personal protective equipment required such as; protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator.

Work is performed standing, walking and bending neck for 6-8 hours per day. Frequently sits for 4-6 hours per day. Frequent movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements of the fingers to grasp and manipulate objects. Occasionally bends and twists neck and waist. Light lifting of 15lbs for 2-4 hours per day with a maximum lift of 50lbs. Hearing acuity essential. Color perception/discrimination, and far vision correctable in one eye to 20/30 and to 20/100 in the other eye.

Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences.

Frequently performs routine tasks by following a set of written or oral instructions/procedures.

EEO/Minorities/Females/Disability/Veterans

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department.

Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter.

All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.

We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Location:

NORTH AMERICA :

USA :

NC-Clayton:
USNC000- Clayton