gmp Jobs in malvern, pa

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Virology Deviation Management Specialist

Zachary Piper Solutions, LLC

•

West Point, Pennsylvania, USA

Full-time

Piper Companies is looking for a Virology Deviation Management Specialist for a leading pharmaceutical manufacturer in West Point, PA. Responsibilities: Conduct microbiological testing within investigations to prove root causeRecommend corrective and preventive actions (CAPAs)Conduct deviation OOS investigations related to testing within pharmaceutical manufacturing Qualifications: 2+ years of experience within GMP/FDA regulated environmentFamiliarity with virology Strong background in pharm
Posted 6 days ago | Updated 9 hours ago

Manager 2 - Process Engineering

Motion Recruitment Partners, LLC

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Horsham, Pennsylvania, USA

Full-time

Principal Process Engineer / Manufacturing Fortune 500 Medical, Biotechnical and Pharmaceutical company is looking to add a Principal Process Engineer to their team in Wilson, NC. This is an initial contract opportunity with perm potential. If you are looking to work for a company that is making a difference for the world you find it. Required Skills & Experience Candidate will need to be commutable distance to Wilson, NC. Role will initially be remote until the Wilson; NC building opens then t
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Posted 30 days ago | Updated 8 hours ago

Supplier Quality Specialist

Zachary Piper Solutions, LLC

•

Malvern, Pennsylvania, USA

Full-time

Piper Health and Sciences is actively seeking a Quality Assurance Specialist - Supplier Quality to work for a large global biotechnology company. Responsibilities for Quality Assurance Specialist - Supplier Quality: Oversee the approved supplier list (ASL) including internal and external audits, sending quality agreements, evaluation, and remediation Responsible for writing, reviewing and revising SOPs, CAPAs, deviations, and change controls End-to-end supplier quality including supplier and ven
Posted 6 days ago | Updated 9 hours ago

Supplier Quality Specialist

Zachary Piper Solutions, LLC

•

Plymouth Meeting, Pennsylvania, USA

Full-time

Piper Health and Sciences is actively seeking a Quality Assurance Specialist - Supplier Quality to work for a large global biotechnology company. Responsibilities for Quality Assurance Specialist - Supplier Quality: Oversee the approved supplier list (ASL) including internal and external audits, sending quality agreements, evaluation, and remediation Responsible for writing, reviewing and revising SOPs, CAPAs, deviations, and change controls End-to-end supplier quality including supplier and ve
Posted 6 days ago | Updated 9 hours ago

Process Engineering

Katalyst Healthcares and Lifesciences

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Philadelphia, Pennsylvania, USA

Full-time

Roles & Responsibilities: Minimum of a bachelor's or equivalent University Degree. minimum of eight (5) years of process/plant engineering experience in GMP MFG large molecule biologics facilities. Experience in green or brown field GMP MFG facility start-up including process systems, automation, utilities, facilities, and operations. Strong technical background in Process and Manufacturing engineering, manufacturing operations and financial fundamentals. Strong analytical skills to synthesize b
Posted 1 day ago | Updated 11 hours ago

Process Engineer

Katalyst Healthcares and Lifesciences

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Conshohocken, Pennsylvania, USA

Full-time

Responsibilities: Lead or support multiple projects simultaneously, ensuring timely and effective execution. Define technical or scientific direction for programs comprising multiple complex projects. Engineer new processes and modify existing ones to ensure right-first-time process start-up. Collaborate with cross-functional teams to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs into actionable solutions. Provide expertise in process sys
Posted 1 day ago | Updated 11 hours ago

Virology Deviation Management Consultant

Zachary Piper Solutions, LLC

•

Lansdale, Pennsylvania, USA

Full-time

Piper Companies is seeking a Deviation Management Consultant to fill an opportunity with a reputable Pharmaceutical company in Lansdale, PA. Responsibilities: Investigate deviations by assessing product impact, identifying root causes, and implementing corrective/preventative actions. Author and update GMP documentation, including SOPs, batch records, validation documents, and change controls. Write quality incident and deviation reports, ensuring thorough analysis and compliance. Collabor
Posted 2 days ago | Updated 9 hours ago

Virology Deviation Management Specialist

Zachary Piper Solutions, LLC

•

West Point, Pennsylvania, USA

Full-time

Piper Companies is looking for a Virology Deviation Management Specialist for a leading pharmaceutical manufacturer in West Point, PA. Responsibilities: Conduct deviation management supporting a Virology quality control team Conduct technical writing of deviation investigation results and initiate CAPAs Fully support all aspects of assigned projects and run the business activities, including but not limited to: participate in decision making, leading laboratory investigations, issue ident
Posted 17 days ago | Updated 9 hours ago

Deviation Management Specialist

Zachary Piper Solutions, LLC

•

Lansdale, Pennsylvania, USA

Full-time

Piper Companies is seeking a Deviation Management Specialist to fill an opportunity with a reputable Pharmaceutical company in Lansdale, PA. Responsibilities for the Deviation Management Specialist Investigate deviations by assessing product impact, identifying root causes, and implementing corrective/preventative actions. Author and update GMP documentation, including SOPs, batch records, validation documents, and change controls. Write quality incident and deviation reports, ensuring thoro
Posted 10 days ago | Updated 9 hours ago

Quality Control Manager

Zachary Piper Solutions, LLC

•

Wayne, Pennsylvania, USA

Full-time

Piper Companies is seeking a Quality Control Manager to join a reputable Biologics Quality Control Testing company located in Wayne, Pa. Responsibilities of the Quality Control Manager include: Lead projects, collaborate with clients and teams, and ensure expectations are met Oversee testing, manage deviations, and ensure adherence to global regulations Represent the team in audits, address issues, and implement corrective actions Manage assay development, validation, and ongoing compliance
Posted 55 days ago | Updated 9 hours ago

QA Clinical Supplies Specialist

Zachary Piper Solutions, LLC

•

Lansdale, Pennsylvania, USA

Full-time

Piper Companies is seeking a QA Clinical Supplies Specialist to join a major pharmaceutical manufacturing company located in Lansdale, PA. This is a Hybrid role. The QA Clinical Supplies Specialist will ensure the quality, compliance and integrity of clinical trial supplies. Responsibilities of the QA Clinical Supplies Specialist include: Ensure clinical supply materials meet company policies and regulatory standards. Lead projects aimed at improving process performance, including yiel
Posted 55 days ago | Updated 9 hours ago

Specialist, Engineering

Merck & Company Inc

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Remote or West Point, Pennsylvania, USA

Full-time

Job Description Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. The West Point Bulk organization is seeking a highly motivated individual for a Specialist -
Posted 1 day ago | Updated 11 hours ago

2nd Shift Specialist, Engineering

Merck & Company Inc

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West Point, Pennsylvania, USA

Full-time

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! ACCOUNTABILITY Under the supervision of a Senior Specialist or Associate Director, is accountable for providing technical manufacturing support in the field of engineering, maintenance and utilities (EMU). Provides off-shift engineering support for assigned area which may include vaccine bulk manufacturing, filling, lyophilization, packag
Posted 12 days ago | Updated 11 hours ago

Business Quality Assurance (BQA)

Activesoft, Inc.

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Remote

Contract

Mandatory Skills & Qualifications: Strong knowledge in GMP, cGMP, and regulatory standards:21 CFR Part 1121 CFR Part 21021 CFR Part 211ICH Q7Experience facing FDA audits at pharmaceutical manufacturing sitesHands-on experience with manufacturing processes, CAPAs, deviations, etc.Lead Auditor or any other compliance certifications (preferred)
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Posted 4 days ago | Updated 7 hours ago

Senior Specialist., Engineering, Maintenance & Utilities

Merck & Company Inc

•

West Point, Pennsylvania, USA

Full-time

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! ACCOUNTABILITY As a member of the Engineering, Maintenance, & Utility Department, is accountable for the management of maintenance and reliability engineers supporting manufacturing areas. This group is responsible for improving asset reliability and manufacturing capacity by providing technical support in the field on engineering resolut
Posted 1 day ago | Updated 11 hours ago

SAP Plant Maintenance (SAP PM)

IT Resonance Inc.

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Remote

Third Party, Contract

SAP Plant Maintenance (SAP PM) 12 months Remote with travel to onsite (Chicago IL) Must have food & beverage manufacturing or consumer packaged goods industry experience Solid/Strong comm skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards Stephen DJA stephen at itresonance dot com
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Posted 29 days ago

Electro Mechanic Specialist

Aspire Bakeries

•

Swedesboro, New Jersey, USA

Full-time

Job Description\n Aspire Bakeries is a North American baking company with a leadership position in specialty frozen baked goods. Formed from leading bakery companies, its innovative food portfolio includes breads, artisan breads, buns, cookies, donuts, muffins and pastries from beloved brands like La Brea Bakery , Otis Spunkmeyer , and Oakrun Farm Bakery . With 13 bakeries in North America, we are committed to driving innovation, predicting upcoming consumer trends and flavors, and exceeding our
Posted 35 days ago | Updated 11 hours ago

Electrical Reliability Engineer

Merck & Company Inc

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West Point, Pennsylvania, USA

Full-time

Job Description Electrical Reliability Engineer, Utilities Reliability Engineering Group Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring missi
Posted 20 days ago | Updated 11 hours ago

Computer System Validation Specialist

SGS Consulting

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Remote

Contract

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r
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Posted 23 days ago

Electro-Mechanical Specialist

Aspire Bakeries

•

Swedesboro, New Jersey, USA

Full-time

Job Description\n Aspire Bakeries is a North American baking company with a leadership position in specialty frozen baked goods. Formed from leading bakery companies, its innovative food portfolio includes breads, artisan breads, buns, cookies, donuts, muffins and pastries from beloved brands like La Brea Bakery , Otis Spunkmeyer , and Oakrun Farm Bakery . With 13 bakeries in North America, we are committed to driving innovation, predicting upcoming consumer trends and flavors, and exceeding our
Posted 16 days ago | Updated 11 hours ago