Equipment Validation Engineer - Trenton, United States - Synectics

Synectics Trenton, United States

3 weeks ago

Description

The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers.

The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures.

Participates in projects and ongoing work activities of low to moderate complexity.

With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope.

As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

eMaintains qualified equipment systems in compliance with policies, guidelines and procedures
Develops qualification protocols, and associated reports while adhering to a change management process.
Supports execution of equipment qualifications and validation protocols for manufacturing and laboratory equipment, utilities and facility
Temperature mapping of Controlled Temperature Units using wired or wireless mapping systems (e.g. Kaye Validator, Kaye ValProbes, Ellabs, etc.)
Supervises vendors for qualification functions.
Develops validation/qualification deliverables such as IOQ Protocols, Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.
Manages projects of limited scope and complexity within their functional area
Supports equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
Completes all qualification and validation documentation with accuracy, completeness and compliance to standards.

Provides excellent customer service and support:
Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
Provides technical support and guidance on equipment qualification issues.
Interfaces with customers to ensure all expectations are being met.
Provides technical support and guidance on equipment and computer systems qualification and validations issues.
Maintains a positive relationship with all team members and site customers while promoting a positive team environment.

Regulatory Responsibilities:
ensure equipment, facilities and programs are maintained in compliance.

Qualifications

BS in Engineering or Science related discipline required
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Experience in the qualification of cell therapy equipment a plus
Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
Strong written and verbal communication skills.
Excellent interpersonal skills with experience dealing with a diverse workforce.
Strong multi-tasking ability in conjunction with proven organizational skills.

Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.

Ability to effectively manage multiple tasks and activities simultaneously.

Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook with extensive background in database systems.

Innate ability to learn new software, such as corporate intranet and enterprise business.
Minimum of 5 years' experience performing/supporting activities in a GMP environment.
Minimum of 3 years' experience in equipment, facility or utility qualification
Highly preferred cell therapy equipment commissioning qualification.

Must Have:
Develops validation/qualification deliverables such as Validation Plans, Requirements
Specifications, Traceability Matrices, Summary Reports, Change Controls.

Benefits

Healthcare Insurance:
Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois.

Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Premiums are subsidized by Synectics.

Dental Insurance:
Synectics offers eligible employees and their dependents a dental plan through MetLife.

Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance:
Synectics offers eligible employees vision insurance through VSP.

Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k)

Plan:
The Synectics Inc. Investment Savings Retirement Plan.

Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins.

Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus:
Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification.

In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us.

Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus.

It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

#J-18808-Ljbffr

Validation Engineer

3 weeks ago

Hyper Recruitment Solutions Ltd Trenton, United States

Job Reference: · J5638077 · Status: · Under Offer · Updated: · 25/08/2023 · We are currently looking for a Validation Engineer to join a leading Pharmaceutical CDMO company based in the New Jersey area. As the Validation Engineer you will be responsible for a range of activiti ...
Validation Engineer

2 weeks ago

Acara Solutions, An Aleron Company Trenton, United States

Acara Solutions is seeking a Validation Engineer for its successful client who are a leading world supplier of integrated processing solutions for customers in the area of pharmaceuticals, food processing, feeds and fine chemicals. Our products and services stand for reliability ...
Validation Engineer

2 weeks ago

ComforceHealth Trenton, United States

Job ID: · Summit , · New Jersey · Job Type: · Contract · Added - 05/08/24 · Job Description · Innova Solutions is immediately hiring for a · Validation Engineer · Position type: Full-time Contract · Duration: · 06 Months · Location: · Summit, NJ Onsite) · As a · Valid ...
Validation Engineer

3 weeks ago

Colsh Consultants LLC. Trenton, United States

· • Own and manage the Information Protection and RiskManagement (IPRM) Processes such as Compliance Solution Profile (CRP)assessment, Data Integrity and Electronic Record Electronic Signature (ERES)assessments and Supplier Control Assessment Process for software solutions. · • ...
Director of Validation Engineering

1 week ago

Renesas Trenton, United States

Renesas · Director of Validation Engineering · Trenton , · New Jersey · Apply Now · As a Director of Validation Engineering, you will be responsible for managing a worldwide team of Silicon validation managers that are responsible to validate new silicon. The team will own d ...
Validation Engineer/Specialist

3 weeks ago

IPS-Integrated Project Services, LLC Trenton, United States

Job Description: · At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated · Validation Engineer · to join our talented team at our office located in · ...
Validation Engineer I, Engineering

3 weeks ago

Amneal Pharmaceuticals Trenton, United States

Job Summary · The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements. · Essential Functions · Assist in the preparation/ execut ...
Senior Validation Engineer

3 weeks ago

Rbw Consulting Trenton, United States

Senior Validation Engineer · Are you a validation expert looking for a new, dynamic environment? · I am partnering with a rapidly growing full service CDMO who are specialised within sterile product development, manufacturing and packaging, and am working with the leadership te ...
Validation Engineer

3 weeks ago

ESCO Lifesciences Group Feasterville-Trevose, United States Full time

Validation Engineer -Laboratory/Pharma Equipment - Trevose, PA 19053. · Use your technical skills and travel the USA Employer Paid Medical InsuranceFrom $70,000/ year - Full-time, Monday to Friday. · Driver's License Required. · 85% Travel Required. · We are searching for an Inst ...
Validation Engineer

3 weeks ago

eTeam Lansdale, United States

Validation Engineer - I (Assistant) · 6 Months contract · West Point, PA · Pay Rate: $35.87/hr on w2 · Position will involve Validation/Metrology tasks but also supporting Finance too. Multi tasking · Normal day- archiving, supporting equipment maintenance. Taking care of the las ...
Senior Equipment Validation Engineer

2 weeks ago

Rbw Consulting Trenton, United States

RBW Consulting are excited to present an opportunity for a · Senior Validation Engineer · with a CDMO partner of ours · With over 20 years experience in the industry, they are passionate about supporting companies from Development to Commercial launch of their Sterile products ...
Senior Validation Engineer/ Specialist

3 weeks ago

IPS-Integrated Project Services, LLC Trenton, United States

Job Description: · At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated · Senior Validation Engineer · to join our talented team at our office located ...
Validation Engineer

1 week ago

Collabera Lansdale, United States

Home · Search Jobs · Job Description · Validation Engineer · Contract: West Point, Pennsylvania, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 10 days, 3 hours left · Apply · Qualifications: · •Associate's degree or higher preferred with 1-2 years of ...
Validation Engineer

6 days ago

Collabera Lansdale, United States

Home · Search Jobs · Job Description · Validation Engineer · Contract: West Point, Pennsylvania, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 9 days, 3 hours left · Apply · Qualifications: · •Associate's degree or higher preferred with 1-2 years of ...
Validation Engineer

3 weeks ago

Joulé Warminster, United States

Title: Automation Validation Engineer - Pharmaceutical · Location: Warminster, PA · Type: 6 Month Contract potential for extension or hire · Schedule: Mon-Fri Day · Overview: Growing Pharmaceutical Company is seeking an Automation Validation Engineering Professional to develo ...
Validation Engineer

3 weeks ago

PAREXEL Horsham, United States Local Office

We are looking to fill a position for a Validation Engineer - Laboratory working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid tim ...
Validation Engineer

1 week ago

Collabera Lansdale, United States

Home · Search Jobs · Job Description · Validation Engineer · Contract: West Point, Pennsylvania, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 13 days, 3 hours left · Apply · Qualifications: · •Associate's degree or higher preferred with 1-2 years of ...
Validation Engineer

3 weeks ago

Integrated Resources Lansdale, United States

*Job Title: *Validation Engineer - I · *Location*: West Point, PA 19486 · *Duration*: 6 Months Contract · *Pay Rate: $35/hr. on W2.* · *Job Description:* · Review, and archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument In ...
Validation Engineer

1 hour ago

Collabera Lansdale, United States

Home · Search Jobs · Job Description · Validation Engineer · Contract: West Point, Pennsylvania, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 4 days, 3 hours left · Apply · Qualifications: · • Associate's degree or higher preferred with 1-2 years of ...
Validation Engineer

1 week ago

Collabera Lansdale, United States

Home · Search Jobs · Job Description · Validation Engineer · Contract: West Point, Pennsylvania, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 15 days, 3 hours left · Apply · Qualifications: · • Associate's degree or higher preferred with 1-2 years o ...