Commissioning and Qualification Specialist Job at Amaris Consulting

Commissioning & Qualification Specialist

Airswift is looking for a Commissioning & Qualification Specialist to work with ...

Location

United States , Birmingham

Salary:

Not provided

Airswift Sweden

Expiration Date

Until further notice

Requirements

Bachelor’s degree preferably in Engineering or Science discipline
3 to 5 experience in validation / qualification of aseptic pharmaceutical processes and / or equipment
Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and GMPs
Comprehensive knowledge of pharmaceutical manufacturing equipment and processes

Job Responsibility

Develop URS, SIC and SRA for new and existing aseptic facilities and equipment
Develop and execute Commissioning (COM) and Installation qualification (IQ) protocols
Perform operational qualification (OQ) and performance qualification (PQ) activities
Ensure all documentation is compliant with regulatory requirements and internal quality standards
Conduct risk assessments and implement mitigation strategies for aseptic processes
Proficient in the use of word processing, spreadsheet and presentation software programs
Proficient in use if Kaye Validator AVS and Val Probe Systems
Knowledge on following equipment qualifications: Homogenizers, Pump Skids, SIP & CIP Skids, Temperature control units, Tanks, Requalification of CTU’s
Develop and implement validation plans for computerized systems
Conduct risk assessments to identify potential issues related to system functionality and data integrity

Area Commissioning Manager

As part of a re-structure, we are creating Area Commissioning Manager roles with...

Location

United Kingdom , Hampton

Salary:

Not provided

MWHTreatment

Expiration Date

Until further notice

Requirements

Relevant degree (electrical, mechanical or process) or other qualification
Site experience in commissioning, preferably in water industry
Electrical SAP qualification desirable
Previous experience as a commissioning manager within a similar industry and size of company

Job Responsibility

Resource and line management within the appointed hub/area
Mentor and manage apprentices and graduates within your hub/area
Day to day management and coordination of all commissioning and commissioning planning activities, including planning for process commissioning and testing, within your hub/region
Ensure Commissioning is carried out safely in accordance with regulations and procedures
Carrying out commissioning activities personally on occasion
Effective engagement with client and operational staff to: Obtain buy-in to proposed commissioning plan
Ensure the effective integration of assets into the existing works without detriment and risk to service level agreements
Achieve fast and effective handovers (including the timely delivery of all commissioning documentation, training, etc)
Act as the "Commissioning Manager" for the purposes of Hazard Studies 4, 5 and 6 for your hub/area and collaborate with other regional commissioning managers to share best practice
Co-operate with the MWHT engineering team to ensure “design for commissioning”

What we offer

A competitive salary
Hybrid Working (Jobs needs dependent)
Car/car allowance (Jobs needs dependent)
25 days holiday + Bank Holidays (with an additional 5 days available to buy)
Contribution Pension scheme
Life Assurance
Health Insurance
Private Medical Insurance
cycle to work scheme
discounts and savings Hub

Fulltime

Site Manager

Are you looking for exciting tasks in a design-oriented company that offers you ...

Location

Germany , Stuttgart

Salary:

Not provided

Henn GmbH

Expiration Date

Until further notice

Requirements

Study in architecture, civil engineering or completed professional training with specialist qualification
Professional experience in building control and site management in German-speaking countries
Preferably experience and an affinity for BIM
Flexibility and a pleasure in the realisation of challenging architecture
Excellent command of German

Job Responsibility

Site management and supervision, including coordination of the specialist construction managers
Technical Lead of employees in the project environment and of external service providers commissioned by us
Construction diary, performance assessment and quality management with systematic defect tracking using DALUX
Scheduling and deadline controlling
Billing, supplementary auditing and supplementary negotiations
Cost controlling and monitoring

What we offer

Diverse projects | Fascinating and well-known large-scale projects with room for creativity
Development opportunities | Access to the HENN Academy for personal and professional development – including recognition by chamber of architects
Language courses | Financial support for German and English courses to support your career
Vacation | 30 days annual leave (including a break between Christmas and New Year's)
Deferred Compensation | Support for your financial security
Coffee culture | Enjoy first-class coffee from our in-house CoffeeBar every day
Work-life balance | Flexible, family-friendly working time models for a balanced lifestyle
Events | Regular joint activities for socializing

Operations Control Center Shift Supervisor

Clearway Energy Group is looking for an Operations Control Center Shift Supervis...

Location

United States , Scottsdale

Salary:

92000.00 - 109000.00 USD / Year

Clearway Energy

Expiration Date

Until further notice

Requirements

Minimum of 5 years of experience in power plant operations
4-year degree or relevant experience may be considered
Able to demonstrate competent technical knowledge of plant and system processes and experience in operating electrical or SCADA systems
Able to interpret NERC, ERCOT, WECC, CAISO, PJM, and SPP regulations and requirements
Available for 24-hour on-call duty to meet obligations to the Operations Team as issues arise
Knowledge of functional system interactions and the ability to pay attention to critical elements in a complex and regulated environment
Ability to make financial decisions based on real-time power plant equipment analysis and contract-related cost weighting, risk versus reward
Ability to coordinate multiple activities and ensure safety, quality, and schedule adherence
Ability to take direction, identify problems, develop solutions, conduct analysis independently and in collaboration with others
Ability to work in difficult customer situations

Job Responsibility

Provide direction and supervision to the on-shift Real-Time Operations Specialist in day-to-day job activities and responsibilities
Manage the RCA and continuous improvement process regarding real-time operations issues, mistakes, and common practices
Assist in proactively monitoring real-time activity, performance, and operational status of all wind, solar, and BESS assets
Assist in Real-Time Operations Specialist in understanding and identifying abnormal operations or alarm conditions that arise during the shift and appropriately troubleshoot in a timely fashion
Perform periodic operator log reviews for accuracy and compliance
Perform acceptance testing on RPMC tools or applications used by the on-shift Operations Specialist
Support the commission activities of new projects
Support and assist in the onboarding process, training, and qualification activities of new operations specialists
Implementation of processes and procedures to assure compliance with internal controls and quality controls for customers and field personnel, and distribute the information to the real-time operations specialists.
Support and assist in RFIs, data requests, and other assigned duties

What we offer

generous PTO
medical, dental & vision care
HSAs with company contributions
health FSAs
dependent daycare FSAs
commuter benefits
relocation
401(k) plan with employer match
a variety of life & accident insurances
fertility programs

Fulltime

Manager Manufacturing, Single Use Systems & Validation

Act as the Manager for the Single Use Systems and Cleaning Validation Team in ou...

Location

United States , Holly Springs

Salary:

126376.00 - 159170.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma/GED and 12 years of biotechnology operations or validation experience
Associate’s degree and 10 years of biotechnology operations or validation experience
Bachelor’s degree and 5 years of biotechnology operations or validation experience
Master’s degree and 3 years of biotechnology operations or validation experience
Doctorate degree

Job Responsibility

Provide technical leadership and subject matter expertise for Single Use Systems and equipment cleaning validation activities in the manufacturing area
Oversee development, implementation, and maintenance of SOPs, training materials, and Quality Management System records related to Single Use Systems and equipment cleaning validation
Lead development and execution of the site’s Cleaning Validation Master Plan (CIP/SIP/COP for equipment and controlled temperature chambers), validation plans, equipment qualification protocols/reports, and cleaning validation strategies
Manage and mentor a team of specialists and engineers, including hiring, training, performance evaluations, and development
Coordinate troubleshooting and support during commissioning, qualification, start-up, and process performance qualification of the facility
Facilitate process, area, and equipment risk assessments to identify risks, failure modes, and mitigating actions
Ensure compliance with regulatory requirements, support regulatory submissions, audits, and inspections
Champion Lean Transformation and operational excellence initiatives, driving continuous improvement in the plant
Collaborate cross-functionally with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure alignment and readiness for new products, process changes, and advanced technologies
Develop and implement training plans and programs to ensure staff are prepared and compliant

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Human Factors Engineer

This role supports execution and monitoring of an integrated Human Factors Engin...

Location

Canada , Pickering

Salary:

60.00 - 70.00 CAD / Hour

Aplin

Expiration Date

Until further notice

Requirements

Must identify proposed HFE personnel in the proposal, including qualifications, training, and experience
Personnel must meet HFE Specialist qualification requirements as defined in relevant standards (e.g., N-INS-06700-10000, N-MAN-06700-10002 Appendix B)
Personnel must be qualified under a Nuclear Design Engineering Qualification Program as a Design Engineer of Human-Machine Interfaces, including Design Engineer qualification and duty area qualification
Qualifications must include completion of nuclear plant HFE design basis training, relevant operating experience, and instrumentation and control computer-based training
Demonstrated CANDU-specific HFE design experience is required to confirm competency for this scope of work

Job Responsibility

Reviewing and providing oversight of Human-Machine Interface (HMI) designs under engineering change control governance
Preparing, reviewing, and accepting HFE analyses and evaluation reports
Providing Subject Matter Expert (SME) recommendations to the Design Team Leader on acceptance of modification-specific documentation
Supporting installation and commissioning through review of construction completion declarations, commissioning reports, and oversight of vendor HFE participation
Identifying significant HFE issues and tracking them to resolution
Confirming that modification-specific HFE documents are included as training and procedure inputs in reference documentation
Supporting regulatory interfaces through meetings, status updates, correspondence review, and inspection interviews
Aggregate HFE analysis to assess aggregate impacts of program modifications on minimum staffing levels

Site Manager

Are you looking for exciting tasks in a design-oriented company that offers you ...

Location

Germany , Stuttgart

Salary:

Not provided

Henn GmbH

Expiration Date

Until further notice

Requirements

Study in architecture, civil engneering or completed professional training with specialist qualification
Professional experience in building control and site management in German-speaking countries
Preferably experience and an affinity for BIM
Flexibility and a pleasure in the realisation of challenging architecture
Excellent command of German

Job Responsibility

Site management and supervision, including coordination of the specialist construction managers
Technical Lead of employees in the project environment and of external service providers commissioned by us
Construction diary, performance assessment and quality management with systematic defect tracking using DALUX
Scheduling and deadline controlling
Billing, supplementary auditing and supplementary negotiations
Cost controlling and monitoring

What we offer

Diverse projects | Fascinating and well-known large-scale projects with room for creativity
Development opportunities | Access to the HENN Academy for personal and professional development – including recognition by chamber of architects
Language courses | Financial support for German and English courses to support your career
Vacation | 30 days annual leave (including a break between Christmas and New Year's)
Deferred Compensation | Support for your financial security
Coffee culture | Enjoy first-class coffee from our in-house CoffeeBar every day
Work-life balance | Flexible, family-friendly working time models for a balanced lifestyle
Events | Regular joint activities for socializing

Site Manager

Are you looking for exciting tasks in a design-oriented company that offers you ...

Location

Germany , Stuttgart

Salary:

Not provided

Henn GmbH

Expiration Date

Until further notice

Requirements

Study in architecture, civil engneering or completed professional training with specialist qualification
Professional experience in building control and site management in German-speaking countries
Preferably experience and an affinity for BIM
Flexibility and a pleasure in the realisation of challenging architecture
Excellent command of German

Job Responsibility

Site management and supervision, including coordination of the specialist construction managers
Technical Lead of employees in the project environment and of external service providers commissioned by us
Construction diary, performance assessment and quality management with systematic defect tracking using DALUX
Scheduling and deadline controlling
Billing, supplementary auditing and supplementary negotiations
Cost controlling and monitoring

What we offer

Diverse projects | Fascinating and well-known large-scale projects with room for creativity
Development opportunities | Access to the HENN Academy for personal and professional development – including recognition by chamber of architects
Language courses | Financial support for German and English courses to support your career
Vacation | 30 days annual leave (including a break between Christmas and New Year's)
Deferred Compensation | Support for your financial security
Coffee culture | Enjoy first-class coffee from our in-house CoffeeBar every day
Work-life balance | Flexible, family-friendly working time models for a balanced lifestyle
Events | Regular joint activities for socializing

Commissioning and Qualification Specialist

Amaris Consulting

Location:
Belgium

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 19, 2026

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February 19, 2026