Engineering to Pharma

Ray Pissed

A friend of mine was involved in the Engineering side of construction for approx. 10 years however he was made redundant in 2009. He eventually did a jobsbridge and obtained a permanent job in the Pharma industry as a Projects/Validation Engineer. The role was to be 5 pronged: Projects - Validation - Utilities - Facilities - Civil/Structural, after 2 years. Note that the Plant is a small facility with approx. 100 employees only.

He is involved with the Engineering Dept. in developing projects however the Engineering/Maintenance Supervisor has a greivence towards him for taking on what was part of his role previously, before the Operations Manager took my friend on. He develops validation plans, URS, IQ/OQ/PQ and risk assessments etc. The role is currently only 2 pronged: Projects - Validation

What my friend finds with the Job is that he has to tip toe his way around engineering in order to develop the project URS, he also finds that for the majority of the time he is doing the donkey work developing document after document, at his desk alone for most of the time. It must be pointed out that there is no Validation Dept. at the company and there is only one other person who approves the documents and drafts the majority of the SOPs.

The company was taken over 3 months ago, and now the Operations Manager is looking to transfer my friend into Utilities - Facilities - EHS (Environmental Health & Safety). However my friend believes that he is now only been transferred into this role in order for the company to develop a QA Validation section within the QA Department.

Utilities: He sees this as daily monitoring of chillers, water plant with the occasional project for replacement of equipment only.

Facilities: He sees this as a role that perhaps only frees up the Maintenance/Engineering Dept.

EHS:There was never a need for an EHS function at the site before, and he sees this as a very redundant and adminstrative role

All in all, he seems to think that he has drawn the short straw on this one. The Operations Manager seems to now get on better with the Maintenance/Engineering Supervisor, where there was a tempered relationship before. My friend feels that there quite alot of work in the future in the area of projects and validation, however he feels that the area of validation will now be transferred from Operations/Engineering to the QA Depeatrment for more QA control etc and projects will be transferred to Maintenance/Engineering. He feels that he now will be placed in another 'sit-in-the-corner' role in isolation etc.

Appreciate any thoughts on this, regarding his employment rights, the job roles etc. Note that he is not aware of the new proposed structure for the company, however QA seem to be pushing for additional staff etc. Should he be pushing for a raise in salary and a more responsible role too.

No role for EHS before? Sounds like he will be busy. I'm working in Pharma (Project Engineer) and EHS is a massive area. If he is head of safety for the entire plant I'd certainly be looking for extra money to go with his extra responsibilities.

Ray Pissed

Dónal wrote: »

No role for EHS before? Sounds like he will be busy. I'm working in Pharma (Project Engineer) and EHS is a massive area. If he is head of safety for the entire plant I'd certainly be looking for extra money to go with his extra responsibilities.

Thanks Donal, note that this Plant does not deal with any hazardous chemicals. The only aspects he sees for EHS are training with regards to use of certain equipment, fire drills, first-aid, site inspections, inputting data on an EHS software program. To him its a role but a very redundant role. The plant has been manufacturing for 25-30 years at the same facility without the need for such a role. Any other thoughts

Ray Pissed

Ray Pissed wrote: »

Thanks Donal, note that this Plant does not deal with any hazardous chemicals. The only aspects he sees for EHS are training with regards to use of certain equipment, fire drills, first-aid, site inspections, inputting data on an EHS software program. To him its a role but a very redundant role. The plant has been manufacturing for 25-30 years at the same facility without the need for such a role. Any other thoughts

How is their explosion protection? Are they ATEX compliant? Are there risks involved in any of the production processes that haven't been assessed?

The main reason for my surprise is that my experience is when EHS isn't seen as a big part of the process, people will cut corners. How many near misses were observed on site last year?

Ray Pissed

Dónal wrote: »

How is their explosion protection? Are they ATEX compliant? Are there risks involved in any of the production processes that haven't been assessed?

The main reason for my surprise is that my experience is when EHS isn't seen as a big part of the process, people will cut corners. How many near misses were observed on site last year?

How is their explosion protection? They use chemicals in the Lab. which are stored in a protected cabinet.

Are they ATEX compliant? No requirement for this.

Are there risks involved in any of the production processes that haven't been assessed? The process is not that complex, no explosive chemicals. My understanding from speaking to him is that the process hasn't much changed and he knows that there have been no serious incidents at the facility.

How many near misses were observed on site last year? From any records, there were only 6-7 first aid treatment incidents.

As you can see from the above this facility is very much low risk and is not high risk like some tableting Plants. Its for this reason that he is concerned about a 'productive role' in the future going forward. Any other comments are welcome.