Commissioning & Qualification Professional Validation Engineer Life SciencesPharma

Please read

Best if the address is mentioned on LinkedIn and the experience is aligned with what is provided on the resume.

Ensure the resume clearly mentions the must-have it can be updated by the candidate/acknowledged by the candidate if any changes are made by you.

Note

Original DL is required along with the last 4 digits of the SSN and DOB (DD/MM).

Please ensure the provided phone number and email ID belong to the candidate and are not marketing or VOIP numbers.

Please provide any and all CVs with ideally 5 years experience who fit within the provided rate.

Job Duration: 2 Years
Job Location: Fogelsville PA (Onsite)
Client: PQE Group
Pay Rate: $50/hr. to $60/hr. on W2 Max (Pay as per the candidate experience)
Visa Requirement: USC and GC candidates only
Location Preference: Need 40-50 miles candidates

LinkedIn Requirement: Need Strong LinkedIn profile (Created before 2020 not recent one)

• Bachelors degree in Engineering Life Sciences or a related technical field
• 6 years of experience in commissioning qualification and/or validation within the pharmaceutical or biotech industry like Amge Genentech Gilead Sciences.
• Hands-on experience in aseptic manufacturing environments
• Strong knowledge of GxP FDA regulations and validation lifecycle requirements
• Experience with black utilities (e.g. WFI clean steam) and/or laboratory analytical equipment qualification
• Familiarity with electronic validation systems such as Kneat is highly preferred
• Prior experience supporting large-scale pharmaceutical manufacturing projects is a plus
• Strong technical writing communication and problem-solving skills
• Ability to work both independently and in a collaborative team environment

• Commissioning & Qualification (C&Q) professionals to support aseptic manufacturing operations within a regulated life sciences environment
• Role will focus on executing commissioning qualification and validation activities for critical systems utilities and laboratory equipment to ensure compliance with GxP and regulatory requirements
• Execute commissioning and qualification (C&Q) activities for aseptic manufacturing equipment utilities and systems
• Develop and/or review protocols including IQ OQ and PQ documentation in alignment with regulatory standards
• Support startup and validation of black utilities (e.g. WFI clean steam process gases)
• Perform qualification activities for laboratory analytical instruments and equipment
• Collaborate cross-functionally with engineering quality validation and manufacturing teams
• Ensure all activities comply with GxP FDA and applicable industry guidelines
• Utilize electronic validation systems (e.g. Kneat) for protocol execution and lifecycle documentation
• Troubleshoot issues during commissioning and qualification phases and support resolution efforts
• Maintain thorough and accurate documentation to support audits and inspections

Please read

Best if the address is mentioned on LinkedIn and the experience is aligned with what is provided on the resume.

Ensure the resume clearly mentions the must-have it can be updated by the candidate/acknowledged by the candidate if any changes are made by you.

Note

Original DL is required along with the last 4 digits of the SSN and DOB (DD/MM).

Please ensure the provided phone number and email ID belong to the candidate and are not marketing or VOIP numbers.

Please provide any and all CVs with ideally 5 years experience who fit within the provided rate.

Job Duration: 2 Years
Job Location: Fogelsville PA (Onsite)
Client: PQE Group
Pay Rate: $50/hr. to $60/hr. on W2 Max (Pay as per the candidate experience)
Visa Requirement: USC and GC candidates only
Location Preference: Need 40-50 miles candidates

LinkedIn Requirement: Need Strong LinkedIn profile (Created before 2020 not recent one)

• Bachelors degree in Engineering Life Sciences or a related technical field
• 6 years of experience in commissioning qualification and/or validation within the pharmaceutical or biotech industry like Amge Genentech Gilead Sciences.
• Hands-on experience in aseptic manufacturing environments
• Strong knowledge of GxP FDA regulations and validation lifecycle requirements
• Experience with black utilities (e.g. WFI clean steam) and/or laboratory analytical equipment qualification
• Familiarity with electronic validation systems such as Kneat is highly preferred
• Prior experience supporting large-scale pharmaceutical manufacturing projects is a plus
• Strong technical writing communication and problem-solving skills
• Ability to work both independently and in a collaborative team environment

• Commissioning & Qualification (C&Q) professionals to support aseptic manufacturing operations within a regulated life sciences environment
• Role will focus on executing commissioning qualification and validation activities for critical systems utilities and laboratory equipment to ensure compliance with GxP and regulatory requirements
• Execute commissioning and qualification (C&Q) activities for aseptic manufacturing equipment utilities and systems
• Develop and/or review protocols including IQ OQ and PQ documentation in alignment with regulatory standards
• Support startup and validation of black utilities (e.g. WFI clean steam process gases)
• Perform qualification activities for laboratory analytical instruments and equipment
• Collaborate cross-functionally with engineering quality validation and manufacturing teams
• Ensure all activities comply with GxP FDA and applicable industry guidelines
• Utilize electronic validation systems (e.g. Kneat) for protocol execution and lifecycle documentation
• Troubleshoot issues during commissioning and qualification phases and support resolution efforts
• Maintain thorough and accurate documentation to support audits and inspections