drjobs Manufacturing Associate II - Contractor

Manufacturing Associate II - Contractor

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1 Vacancy
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Job Location drjobs

Baltimore, MD - USA

Hourly Salary drjobs

USD 27 - 28

Vacancy

1 Vacancy

Job Description

Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams. All communication will come from an email address ending If you receive a message that seems suspicious or is not from our official domain please report it immediately toemailprotected.

This is a temporary 36month contracted 1099 position withno benefits.

SHIFT 7AM 7PM (223 ROTATION)
The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process through the application of broad knowledge of theories and principles utilized to solve operational as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing.

Lifting to 40 lbs. unassisted may be required at times.
Frequent standing and walking is required as this role requires presence on the manufacturing floor.
Shift work and weekend work is required.

KEY RESPONSIBILITIES:
Completes Batch Production Records under cGMP and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps
Generates operational protocol(s) internal or external documents including SOPs BPRs deviations and summary reports
May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP
Generate and revise internal and external documents (SOPs BRs)
Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs
Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment
Recommend equipment and other supply purchases within the production areas
Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions
Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
Work closely with various departments and aid other teams as necessary
Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the personinplant (PIP) during manufacturing campaigns
Participate in facility expansion and equipment validation activities
Is fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines
Other duties as assigned

Education & Experience:
HS or GED with 47 years experience with upstream (fermentation/bioreactor) or downstream (column chromatography buffer/media skid) biologic production processes under GMP compliance
OR
Associates degree in a Scientific Engineering or Biotech field with 24 years experience with upstream (fermentation/bioreactor) or downstream (column chromatography buffer/media skid) biologic production processes under GMP compliance
OR
Bachelors degree in a Scientific Engineering or Biotech field with 13 years experience with upstream (fermentation/bioreactor) or downstream (column chromatography buffer/media skid) biologic production processes under GMP compliance
Outstanding knowledge and ability to apply scientific principles utilized to solve operational as well as routine production tasks
Excellent documentation skills including comprehension review & establishing Batch Production Records SOPs deviation & summary reports
Thorough knowledge of current Good Manufacturing Practices (cGMPs) and all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.
Must be teamoriented (proactively builds healthy working relationships between peers their department and other groups).
Able to fluently communicate in English. Exhibits excellent written and oral communication skills.
Possesses a basic knowledge of nonmanufacturing functions such as QC Regulatory QA and/or Materials Management.

Required Experience:

Manager

Employment Type

Full-Time

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