Biopharm Manufacturing Associate Ii Jobs

Experience with leading/executing process validation activities (installation qualifications, process characterization, operational and performance qualifications)

May incorporate inspection and test requirements into the production plan.

Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Experience with DFMEA and PFMEA

Experience with design of experiment (DOE) and other statistical methods

Applies acquired job skills and company policies and procedures to complete assigned tasks.

Sampling of in process and raw materials.

Running glass washer / autoclave.

Equipment preparation (CIP / SIP).

Cell culture (from vial thaw to production scale).

Works on assignments that are semi-routine in nature but recognizes the need for occasional deviation from accepted practice.

Working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.

The technical transfer engineer establishes appropriate team roles and responsibilities for activities at the site they represent.

2 - 5 years experience in industry. Medical device, consumer, automotive, and aerospace preferred.

1-2 years experience in new product introductions/manufacturing/ manufacturing science and technology/technical development/R&D.

Specific experience in mechanical, electromechanical, or opto-mechanical design.

Experience working in a cross-functional environment (e.g. multi-site, technical development, other functions).

Troubleshooting parts that have a fit/functionality issue, and require evaluation and disposition.

The updating and creation of BOMS, routings, etc. for all assigned product lines.

The highlighting of drawings for either inspection or rework purposes, for Incoming Inspection, the supplier(s) and/or the Nova machine shop.

The writing of ECO's, MV's, and Pilot Release forms to pre-release and/or update, edit, deviate from existing assembly documentation.

BS Mechanical Engineering and 5-10 years in a manufacturing engineering environment.

A functional competence in Solidworks, Excel, Microsoft Word, Microsoft Project.

Improve process methods which meet performance and quality requirements.

Ability to balance quality, compliance and safety to meet customer requirements.

Good problem-solving skills through the use of quality and statistical tools.

Demonstrates good written and verbal communication skills.

Assist in maintaining and improving controlled technical documents such as prints, procedures, bill of materials and routers.

Support a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc.

Communicate manufacturing problems or ideas for operation efficiency improvement with management.

Skills/ Abilities Pertinent To, This Position

Assembly Experience in clean rooms minimum two years

Make sure to finish all products on time.

Test assembly product and sub-assembly.

Keep accurate records of product produced and finish appropriate paperwork of operations related to manufacturing.

Project Management skills to manage projects from quotation to implementation

Processing knowledge to manage Tooling trials

Experience with Injection molding and or Metal Stamping (preferably automotive)

Any CAD/CATIA experience is a plus

Manage tooling projects from design through mass production

Job Title: Manufacturing Engineer II

Solid experience with and knowledge of process flows, Time Studies, Capacity Planning.

3+ years of experience in Manufacturing Engineering/Process Development.

Experience in electrical or electronics products including heaving wiring a plus.

Experience with battery packs or switchgear a plus.

CAD experience, preferably AutoCAD but will look at others.

Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Demonstrate general knowledge of standard manufacturing practices and equipment.

Utilize knowledge to improve operational efficiency.

Exceptional written, oral communication, and organizational skills required

Family care benefits, including subsidized back-up care options and on-demand tutoring

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Here’s What You’ll Bring to the Table:

Generous paid time off, including:

An equivalent combination of education and experience may be considered

Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.

Strong planning, organization, and multitasking skills.

Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

Bachelor’s degree with 0+ years of cGMP industry experience preferred.

Biotech program certificate or equivalent and 1+ years of cGMP industry experience preferred.

In addition to offering a great culture and work environment, Vertos also offers the following benefits:

Minimum of two years of relevant experience.

Knowledge of statistical techniques including descriptive/inferential statistics and DOE.

SolidWorks or other mechanical design program experience.

Experience in a manufacturing environment - designing, specifying, fabricating, assembling, measuring, validating, debugging machinery / product and manufacturing processes.

Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design).

Basic knowledge of buffer solution preparation or purification processing is preferred

Experience in single-use platform technology is preferred

Excellent written and verbal communication skills are required

Energetic, motivated and dynamic individual.

Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

Support engineering and project management in FAT, installation, and commissioning of the new assembly line.

2+ years of experience in manufacturing engineering, mechanical engineering, or related field.

Demonstrated interest and experience supporting manufacturing operations, troubleshooting automation equipment, and implementing process improvements.

Demonstrated experience writing and executing validations (IQ, OQ, PV, etc.).

High speed custom automation experience.

Support development of the process FMEA and control plan for the new assembly process.

Hands-on experience in a pharmaceutical, biotech, drug manufacturing, or academic environment is required, with knowledge of clean room practices being essential.

Experience using basic laboratory equipment; knowledge of safe laboratory procedures.

Experience and knowledge in iPSC cell culture techniques, including culturing and maintenance.

Demonstrated experience with aseptic cell culture methods, including cryopreserving, thawing, and expanding cell lines, is required.

Strong computer skills using MS Word, Excel and email.

Strong organizational skills with ability to prioritize tasks and to work under the pressure of multiple demands.

Project management, processing, validation and manufacturing line support experience preferred

Identifies, implements, and manages equipment requirements to support production goals.

Characterizes the physical and material properties of the components, and optimizes these properties against device performance requirements

Completes and manages Capital Equipment Request Authorizations (CERA’s).

2-4 years of relevant work experience

Experience working in the medical device industry

Adhere to the Quality Management Systems

Inspect finished product to assure adherence to specifications such as appearance, foreign substances and packaging or labeling requirements as required.

High School Diploma plus 1 year of related experience.

1-2 years of specific industry experience.

Strong interpersonal and communications skills; written and oral.

Comply with all company policies including; safety, training, GDP (Good Documentation Practices), clean room gowning, attendance, and PTO (Paid Time Off).

Troubleshoots manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of management.

Minimum of two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions, previous biopharmaceutical experience preferred

Detail oriented with strong written and verbal communication skills.

Familiarity with cGMP, manufacturing, machine operations, and data entry.

Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility.

Assists technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment.

Adhere to the Quality Management Systems

Inspect finished product to assure adherence to specifications such as appearance, foreign substances and packaging or labeling requirements as required.

High School Diploma plus 1 year of related experience.

1-2 years of specific industry experience.

Strong interpersonal and communications skills; written and oral.

Comply with all company policies including; safety, training, GDP (Good Documentation Practices), clean room gowning, attendance, and PTO (Paid Time Off).

Acts as a resource for colleagues with less experience; may lead small projects with manageable risks and resource requirements

Demonstrates conceptual and practical expertise in own discipline and basic knowledge of related disciplines

May coordinate outsourcing activities with external / internal suppliers.

Performs Process Failure Mode, Effects and Criticality Analysis when working with New Product Development.

Solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information

Explains difficult or sensitive information; works to build consensus