* specializing in comprehensive CQV (Commissioning, Qualification, and Validation) and engineering solutions tailored exclusively for the dynamic life science industry. We provide a full spectrum of ...
Katalyst
60 jobs near Andover, MA
* specializing in comprehensive CQV (Commissioning, Qualification, and Validation) and engineering solutions tailored exclusively for the dynamic life science industry. We provide a full spectrum of ...
* Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management. * Maintains a state of ...
* Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management. * Maintains a state of ...
Job Summary: Senior CQV Engineer / Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments.
Job Summary: Senior CQV Engineer / Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments.
Senior Design Quality Engineer
$89.50K - $121.30K/yr
Summary: As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end design quality and ...
Senior Design Quality Engineer
$89.50K - $121.30K/yr
Summary: As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end design quality and ...
Sr Quality Engineer
$94.20K - $127.70K/yr
Responsibilities: * Provide Quality Engineering support for commercial medical device products. * Develop, modify, apply and maintain quality standards and protocol for processing materials into ...
Sr Quality Engineer
$94.20K - $127.70K/yr
Responsibilities: * Provide Quality Engineering support for commercial medical device products. * Develop, modify, apply and maintain quality standards and protocol for processing materials into ...
Quality Engineer
$78.40K - $101.20K/yr
Responsibilities: * Develop, implement, and maintain robust quality management systems aligned with industry standards such as ISO 13485, ISO 9001, and regulatory requirements including FDA ...
Quality Engineer
$78.40K - $101.20K/yr
Responsibilities: * Develop, implement, and maintain robust quality management systems aligned with industry standards such as ISO 13485, ISO 9001, and regulatory requirements including FDA ...
Quality Engineer
$78.70K - $101.60K/yr
We are looking for an experienced CAPA Quality Engineer to drive CAPA initiatives, support project management activities, and communicate effectively across teams. The ideal candidate brings a ...
Quality Engineer
$78.70K - $101.60K/yr
We are looking for an experienced CAPA Quality Engineer to drive CAPA initiatives, support project management activities, and communicate effectively across teams. The ideal candidate brings a ...
Summary : The Supplier Quality engineer will work closely with our suppliers and purchasing group to resolve supplier issues and prevent their reoccurrence. Applies and maintains standards for ...
Summary : The Supplier Quality engineer will work closely with our suppliers and purchasing group to resolve supplier issues and prevent their reoccurrence. Applies and maintains standards for ...
* The Product Complaint Manager is responsible for supporting the Product Complaint Quality System at our client. * This role will support quality activities associated within the Small Molecule ...
* The Product Complaint Manager is responsible for supporting the Product Complaint Quality System at our client. * This role will support quality activities associated within the Small Molecule ...
Quality Engineer
$80.70K - $104.20K/yr
Job Summary: * Medical Device Quality Engineer responsible for supporting the launch of a new medical device product into production at an onsite manufacturing facility in Devens, MA. * The role ...
Quality Engineer
$80.70K - $104.20K/yr
Job Summary: * Medical Device Quality Engineer responsible for supporting the launch of a new medical device product into production at an onsite manufacturing facility in Devens, MA. * The role ...
* We are seeking a highly skilled and experienced Manager, Quality Analytics to join our Quality Assurance team. This role is pivotal in driving data-driven decision-making and strategic process ...
* We are seeking a highly skilled and experienced Manager, Quality Analytics to join our Quality Assurance team. This role is pivotal in driving data-driven decision-making and strategic process ...
Responsibilities: * Lead and manage publishing activities for IND, NDA, ANDA, Amendments, Supplements, Responses, Annual Reports, Safety Reports, and Promotional Submissions. * Oversee submission ...
Responsibilities: * Lead and manage publishing activities for IND, NDA, ANDA, Amendments, Supplements, Responses, Annual Reports, Safety Reports, and Promotional Submissions. * Oversee submission ...
CSV Lead / Manager
$17.50 - $21.25/hr
Job Summary: * Responsible for leading and maturing the Validation / Computer System Validation (CSV) program, ensuring compliance with GxP and FDA requirements. * The role focuses on driving ...
CSV Lead / Manager
$17.50 - $21.25/hr
Job Summary: * Responsible for leading and maturing the Validation / Computer System Validation (CSV) program, ensuring compliance with GxP and FDA requirements. * The role focuses on driving ...
Roles & Responsibilities: * Serve as the subject matter expert for planning, setup, and acquisition of external clinical data at the study level, managing study startup, conduct, and closeout ...
Roles & Responsibilities: * Serve as the subject matter expert for planning, setup, and acquisition of external clinical data at the study level, managing study startup, conduct, and closeout ...
Technical/Functional Skills : • Medical Device Domain Experience • Good understanding of ISO 13485, ISO19471, 21CFR PART 11 & 21CFR PART 820 • Knowledge of Gage R&R, QFD, MSA, AAA, Hypothesis ...
Technical/Functional Skills : • Medical Device Domain Experience • Good understanding of ISO 13485, ISO19471, 21CFR PART 11 & 21CFR PART 820 • Knowledge of Gage R&R, QFD, MSA, AAA, Hypothesis ...
Senior Manufacturing Engineer
$92K - $125.80K/yr
: Contract Senior Manufacturing Engineer Reports to: Manufacturing Engineering Manager Department of Manufacturing Engineering focuses on manufacturing at our headquarters in Andover Massachusetts. The ...
Senior Manufacturing Engineer
$92K - $125.80K/yr
: Contract Senior Manufacturing Engineer Reports to: Manufacturing Engineering Manager Department of Manufacturing Engineering focuses on manufacturing at our headquarters in Andover Massachusetts. The ...
Responsibilities: * Lead clinical data management activities for pivotal trials, ensuring data quality and integrity * Collaborate with cross-functional teams to support clinical trial data ...
Responsibilities: * Lead clinical data management activities for pivotal trials, ensuring data quality and integrity * Collaborate with cross-functional teams to support clinical trial data ...
Associate Scientist is responsible for the development of robust, efficient, scalable and transferable lentiviral vector (LVV) manufacturing for early and late-stage cell therapy programs, for both ...
Associate Scientist is responsible for the development of robust, efficient, scalable and transferable lentiviral vector (LVV) manufacturing for early and late-stage cell therapy programs, for both ...
Summary: Seeking an experienced CSV/CSA Consultant to support validation of SaaS and enterprise systems in a GMP environment. This role involves cloud system validation, equipment qualification, and ...
Summary: Seeking an experienced CSV/CSA Consultant to support validation of SaaS and enterprise systems in a GMP environment. This role involves cloud system validation, equipment qualification, and ...
* You are responsible for managing activities related to post-market product safety surveillance and risk management. * Serves as a liaison between Medical Affairs, Clinical Affairs, Research ...
* You are responsible for managing activities related to post-market product safety surveillance and risk management. * Serves as a liaison between Medical Affairs, Clinical Affairs, Research ...
Job description
Job Description:
- specializing in comprehensive CQV (Commissioning, Qualification, and Validation) and engineering solutions tailored exclusively for the dynamic life science industry. We provide a full spectrum of services, including facilities, utilities, process, and automation engineering, top-tier quality, compliance, and regulatory affairs consulting, and innovative recruiting solutions. Our commitment extends beyond consulting, as we aim to be the next-generation partner providing total talent solutions to our partners, ensuring success at every stage of their journey.
- We are looking for a highly motivated mid-level CQV engineer (5+ Years of Experience) with good interpersonal skills to join Omni as a C&Q engineer / consultant supporting our clients' project execution at their pharmaceutical manufacturing facility. This position is a field-based, execution-oriented role and part of a project team focused on delivering commissioning and qualification activities.
- The ideal candidate will have hands-on experience with GMP systems, familiarity with utilities and automation-controlled process equipment and cleaning validation.
- we embrace diversity including valuing everyone's unique skills. Omni truly believe to grow together with our employees and clients; our employees are our assets! Matching experienced US residents and Canadian citizens are encouraged to apply.
- Assist in implementing acceptance criteria, specifications, root cause analysis and corrective action plans.
- Collaborate with Engineering, QA, Automation, and construction teams to ensure systems are delivered per GMP and project standards.
- AHUs and Cleanroom HVAC systems.
- Water for Injection (WFI).
- Clean steam.
- Compressed air and process gases.
- CIP/SIP systems.
- Fermenters.
- Chromatography skids.
- Tangential Flow Filtration (TFF) units.
- Buffer prep and hold tanks.
- Centrifuges.
- Formulation vessels and associated skids.
- Parts Washers.
- Autoclaves.
- HPLC.
- Lyophilizer.
- Experienced with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Bachelor's degree in Engineering or similar technical field.
- 5+ years of commissioning, qualification and validation experience in Pharmaceutical/biotech and/or Medical Device industry.
- Must have experience with qualification, commissioning / decommissioning and validation for process support equipment and / or automation system and / or utilities systems.
- Experience with CTE (controlled Temperature Environment) temp. mapping is highly desired.
- 1+ Years of Experience (YOE) with independent Cleaning Validation protocol generation and execution experience.
- Proficiency with Veeva VMS, Kneat, and or ValGenesis for protocol development, execution, and documentation.
- Familiarity with P&IDs, interpreting engineering and source documentation (URS, FS, Owner's Manual), and protocol execution standards in order to generate detailed test scripts to verify requirements are met.
- Must be able to communicate clearly (written, verbal), Collaborative mindset and ability to work autonomously and effectively within cross-functional teams.
- Must have experience working on and contributing to project teams.
- Ability to independently perform basic troubleshooting to rule out errors in setup, testing, protocol discrepancy, etc and propose solutions.
- Project experience in greenfield and or facility expansion projects.
- Exposure to operating equipment that is controlled by a building management/automation system (e.g. DeltaV, SCADA, Rockwell PAx).
- Experience using commissioning tracking tools or turnover documentation systems.
- Cleaning Validation of process equipment including experience performing cleaning cycle development, rinse sampling, surface swabbing, visual inspections to support cleaning verification or cleaning validation.
- Prior testing experience on systems that use Unicorn software.
- Experience executing Computer Software Assurance (CSA) testing for manufacturing process equipment.
- Experience performing periodic reviews to evaluate if the validated state has been maintained and the completion of requalification.